Pharmacovigilance Jobs

Why This Role MattersPharmacovigilance is essential for ensuring the safety and effectiveness of medicines throughout their lifecycle. From clinical trials to post-marketing surveillance, pharmacovigilance professionals monitor adverse events, analyze safety data, and ensure that pharmaceutical products comply with global regulatory requirements. The Pharmacovigilance Associate role at Alvotech plays a key part in supporting global safety data management for biosimilar medicines. The position contributes to the monitoring of safety data generated from clinical trials and post-marketing programs while maintaining compliance with international pharmacovigilance regulations.Working within the Global Safety Data Management team, the PV Associate will assist in managing adverse event reports, monitoring safety signals, and supporting pharmacovigilance system operations. This role also contributes to improving pharmacovigilance processes and ensuring regulatory compliance across global safety programs. For professionals with pharmacovigilance experience, this role offers valuable exposure to global drug safety operations, safety databases, and regulatory frameworks governing biosimilar medicines.Job DescriptionAlvotech is seeking a motivated Pharmacovigilance Associate to support clinical safety and post-marketing pharmacovigilance activities within its Research and Development function. The selected candidate will be part of the Global Safety Data Management team and will contribute to safety data handling, regulatory reporting, and pharmacovigilance process development. The role involves working with safety databases, managing adverse event cases, and ensuring that safety information is processed in accordance with international regulatory requirements.The PV Associate will collaborate with multiple internal departments and external partners to ensure timely safety reporting and regulatory compliance across global clinical and post-marketing programs.Key Features of the Role• Opportunity to work within global pharmacovigilance and safety data management• Exposure to clinical trial safety monitoring and post-marketing surveillance• Involvement in pharmacovigilance system configuration and lifecycle management• Collaboration with global regulatory, quality, and clinical teams• Participation in safety process improvement and compliance initiatives• Opportunity to support safety monitoring for biosimilar medicinesResponsibilitiesClinical Safety & Pharmacovigilance Activities• Support assigned clinical safety and post-marketing pharmacovigilance activities• Manage Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) processing• Assist in regulatory safety submissions and reporting requirements• Perform literature monitoring and digital platform monitoring for safety signals• Conduct pharmacovigilance reconciliations and safety data verification• Support activities related to EudraVigilance and XEVMPDSafety Systems & Data Management• Assist in configuration, validation, and lifecycle management of pharmacovigilance systems• Maintain safety databases and ensure accurate safety data management• Work with safety systems such as Oracle Argus Safety, ARISg Safety System, and Veeva Vault SafetyPharmacovigilance Process Support• Assist in maintaining and optimizing global pharmacovigilance procedures• Ensure compliance with internal SOPs and international safety regulations• Support safety documentation and regulatory compliance activitiesCross-Functional Collaboration• Work with pharmacovigilance teams involved in benefit-risk management and clinical trials• Collaborate with departments such as Quality, Regulatory Affairs, IT, and Clinical Program Development• Coordinate with external pharmacovigilance service providers and business partnersTraining, Audits & Compliance• Support pharmacovigilance training for internal staff and external stakeholders• Assist in safety-related audits and regulatory inspections• Maintain accurate documentation to meet global regulatory requirementsRequired QualificationsEducational Requirements• Master’s degree in Pharmaceutical Sciences, Pharmacy, Medicine, or Life SciencesExperience and Skills• Minimum 2 years of experience in Pharmacovigilance or Drug Safety• Experience working in safety data management functions• Hands-on experience in clinical trial safety and post-marketing pharmacovigilance• Familiarity with pharmacovigilance safety databases• Experience working with global pharmaceutical products and clinical trials• Knowledge of biologic or combination products is considered an advantageRegulatory Knowledge• Understanding of global pharmacovigilance regulations including• ICH Guidelines• FDA Regulations• Good Pharmacovigilance Practices• Good Clinical Practice• Council for International Organizations of Medical Sciences safety reporting standardsProfessional Skills• Strong organizational and time-management skills• Excellent written and verbal communication abilities• Ability to manage multiple safety activities and meet deadlines• Capability to work independently and collaboratively in multicultural teamsSalary InsightsAlthough the exact salary has not been specified, Pharmacovigilance Associate roles in the global biopharmaceutical industry typically offer competitive compensation based on experience, location, and expertise. Employees may also receive additional benefits such as professional development opportunities, global project exposure, and involvement in innovative biosimilar research programs.Company OverviewAlvotech is a global biopharmaceutical company focused on developing and manufacturing high-quality biosimilar medicines.The company specializes in improving access to biologic treatments by producing cost-effective biosimilars while maintaining strict regulatory, safety, and quality standards. Within its Research and Development division, the Integrated Clinical and Medical Research department develops strategies aligned with global biosimilar guidelines and regulatory authority requirements to support successful clinical studies and post-marketing safety programs.Through advanced pharmacovigilance systems and global safety monitoring processes, Alvotech ensures that its biosimilar medicines meet international safety and regulatory standards.FAQsWho can apply for this role?Candidates with a Master’s degree in Pharmacy, Life Sciences, or Medicine and at least 2 years of pharmacovigilance experience.What type of work does the PV Associate perform?The role involves adverse event case processing, safety monitoring, regulatory reporting, safety database management, and pharmacovigilance compliance activities.Is experience with safety databases required?Yes. Experience with systems such as Argus, ARISg, or Veeva Vault Safety is preferred.Does the role involve working with clinical trials?Yes. The position supports safety monitoring for both clinical trials and post-marketing pharmacovigilance programs.Application Tips• Highlight your pharmacovigilance experience and safety data management expertise• Include experience working with ICSR processing and SAE reporting• Mention knowledge of safety databases such as Argus or Veeva Vault Safety• Demonstrate familiarity with global PV regulations such as ICH, GVP, and GCP guidelines• Emphasize strong documentation practices and attention to detail

Why This Role MattersThe Senior Associate – Data Sciences in Global Market Vigilance plays a key role in monitoring product safety and post-market surveillance data across global markets. The position focuses on safety analytics, signal detection, and regulatory compliance to ensure that adverse event trends are identified early and managed effectively, supporting consumer safety and regulatory requirements.Job DescriptionUnilever is hiring a Senior Associate – Data Sciences within the Global Market Vigilance (GMV) team at its R&D center in Bengaluru. The role focuses on pharmacovigilance data analytics, adverse event case management, and signal detection activities while ensuring compliance with global regulatory standards and maintaining inspection readiness.Key Features of the Role• Opportunity to work in global pharmacovigilance and safety data analytics• Exposure to post-market surveillance and safety monitoring processes• Hands-on work with safety databases and advanced analytics tools• Collaboration with regulatory affairs, R&D, and quality teams• Involvement in global adverse event trending and signal detection activitiesResponsibilitiesCase Management and Compliance• Lead or perform adverse event intake, triage, and documentation using safety systems such as Veeva Vault Safety• Conduct duplicate checks and ensure high-quality safety data for analysis• Perform seriousness, causality, and expectedness assessments with proper documentation• Ensure compliance with MedDRA coding standards, SOPs, and global adverse event reporting requirementsSafety Data Analytics, Trending and Signal Detection• Perform quantitative and qualitative safety data analysis across brands and markets• Develop dashboards, KPIs, and safety scorecards for monitoring trends• Conduct global adverse event trending, signal detection, and safety pattern analysis• Validate potential safety signals through case series evaluation and confounder assessments• Support automation initiatives across the pharmacovigilance lifecycleSystem and Process Optimization• Support configuration, testing, and validation of pharmacovigilance safety databases• Perform safety data audits, reconciliation, and root cause investigations• Implement process improvements to enhance data integrity and analytics readinessCross-Functional Collaboration and Leadership• Act as the analytics and safety contact for regulatory affairs, R&D, quality teams, and customer support groups• Present safety trends, risks, and signals to stakeholders and governance forums• Mentor junior associates in pharmacovigilance analytics and documentation standards• Drive corrective and preventive actions related to safety data issuesRequired QualificationsEducational Requirements• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related fieldExperience and Skills• 5–8 years of experience in pharmacovigilance, safety analytics, or global market vigilance• Hands-on experience with pharmacovigilance systems such as Veeva Vault Safety or similar platforms• Strong knowledge of safety data trending, signal detection, and pharmacovigilance analytics• Experience with analytics tools such as Power BI, Tableau, SQL, or advanced Excel• Familiarity with automation or AI-enabled pharmacovigilance workflows• Strong understanding of audit readiness, quality management systems, and vendor oversight]Salary InsightsSalary details were not specified in the job posting and are expected to be offered as per company standards and experience.Company OverviewUnilever is a global consumer goods company known for its wide portfolio of health, beauty, and wellbeing products. The company invests heavily in research and development to ensure product safety, quality, and regulatory compliance across international markets.FAQs• What qualification is required for this role?Candidates should have a bachelor’s or master’s degree in life sciences, pharmacy, or a related discipline.• How much experience is required?Applicants should have approximately 5–8 years of experience in pharmacovigilance, safety analytics, or post-market surveillance.• Where is the job located?The role is based at the Unilever R&D center in Bengaluru, Karnataka.• What type of work will the candidate perform?The role involves pharmacovigilance data analytics, adverse event case management, signal detection, and safety trend monitoring.Application Tips• Highlight experience in pharmacovigilance systems and safety data analysis• Mention knowledge of MedDRA coding and adverse event processing• Include experience with analytics tools such as Power BI, Tableau, or SQL• Showcase expertise in signal detection and pharmacovigilance compliance• Demonstrate strong documentation and regulatory compliance skills

Why This Role MattersThese roles play an important role in supporting clinical research operations, drug safety monitoring, regulatory compliance, and clinical data management. Professionals in these positions contribute to maintaining high standards of patient safety, regulatory accuracy, and data integrity across pharmaceutical and clinical research projects.Job DescriptionBioclinaarc is currently recruiting life science professionals for multiple positions including Data Manager, Pharmacovigilance / Drug Safety Associate, and Regulatory Affairs Associate. These roles involve managing clinical trial data, monitoring drug safety reports, and supporting regulatory submissions to ensure compliance with international regulatory standards.Key Features of the RoleOpportunity to work in clinical research, drug safety, and regulatory affairsExposure to global standards including ICH-GCP and regulatory compliance frameworksInvolvement in clinical data management and pharmacovigilance operationsCollaboration with clinical research, regulatory, and biostatistics teamsCareer growth opportunities in pharmaceutical and clinical research industriesAvailable Positions & VacanciesPosition – VacanciesData Manager – 1Pharmacovigilance / Drug Safety Associate – 1Regulatory Affairs Associate – 2ResponsibilitiesData ManagerManage and maintain clinical trial datasets and databasesPerform data validation, query management, and data cleaningEnsure compliance with ICH-GCP, CDISC standards, and regulatory guidelinesCoordinate with clinical research teams and biostatistics teamsPharmacovigilance / Drug Safety AssociateProcess adverse event (AE) and serious adverse event (SAE) reportsPerform MedDRA coding and case narrative preparationConduct case triage, literature screening, and signal detectionMaintain compliance with global pharmacovigilance regulationsRegulatory Affairs AssociatePrepare and review regulatory submissions and dossiersMaintain regulatory documentation and compliance recordsSupport regulatory strategy and product lifecycle managementCoordinate with regulatory agencies and internal teamsRequired QualificationsEducational RequirementsB.Pharm / M.PharmMSc in Life Sciences or related disciplinesExperience and SkillsKnowledge of clinical research processes and regulatory complianceUnderstanding of pharmacovigilance and drug safety reporting systemsFamiliarity with clinical data management practices and standardsGood analytical, documentation, and communication skillsAbility to work collaboratively in cross-functional teamsSalary InsightsData Manager – ₹5 – ₹9 LPAPharmacovigilance Associate – ₹4 – ₹8 LPARegulatory Affairs Associate – ₹4 – ₹9 LPACompany OverviewBioclinaarc is a clinical research and pharmaceutical services organization supporting global drug development activities. The company works across domains such as pharmacovigilance, regulatory affairs, clinical data management, and biostatistics to support safe and effective pharmaceutical research.FAQsWhat qualifications are required for these roles?Candidates should have B.Pharm, M.Pharm, or MSc in Life Sciences or related fields.Which roles are currently open?The company is hiring for Data Manager, Pharmacovigilance / Drug Safety Associate, and Regulatory Affairs Associate.What is the expected salary range?The estimated salary ranges from ₹4 LPA to ₹9 LPA depending on the role and experience.What type of work will candidates perform?The roles involve clinical data management, drug safety monitoring, and regulatory documentation activities.Application TipsHighlight experience or internships in clinical research, pharmacovigilance, or regulatory affairsMention familiarity with tools like MedDRA, CDISC, or clinical databasesShowcase strong documentation and analytical skillsInclude knowledge of ICH-GCP and global regulatory guidelinesEmphasize teamwork and communication skills in clinical research environments

Why This Role MattersThe QMS Associate / QMS Executive plays an important role in maintaining quality and regulatory compliance within a Clinical Research Organization. The position supports the implementation and monitoring of the Quality Management System (QMS), ensuring that clinical research activities follow global regulatory standards and best practices.Job DescriptionThe QMS Executive will support quality assurance activities including internal audits, regulatory compliance monitoring, documentation control, and continuous improvement of quality systems. The role ensures that clinical research operations align with regulatory guidelines such as ICH-GCP while maintaining proper documentation and audit readiness.Key Features of the Role• Opportunity to work in Quality Management within a Clinical Research Organization• Exposure to global regulatory standards including ICH-GCP, USFDA, EMA, and CDSCO• Involvement in internal audits, compliance monitoring, and quality improvement initiatives• Collaboration with cross-functional teams including clinical operations and pharmacovigilance• Professional growth in clinical research quality systems and regulatory complianceResponsibilities• Implement and monitor Quality Management System (QMS) processes in accordance with global regulatory guidelines• Conduct internal audits, vendor audits, and study-related audits to ensure compliance with SOPs and regulatory requirements• Assist in preparation, review, and maintenance of SOPs, CAPAs, deviations, and change control documentation• Support regulatory inspections and client audits by ensuring documentation readiness and compliance• Maintain training records and ensure staff compliance with required quality and regulatory training programs• Identify process gaps and recommend corrective and preventive actions to improve quality systems• Maintain accurate documentation, record-keeping, and archival systems• Collaborate with departments such as Clinical Operations, Pharmacovigilance, Data Management, and Regulatory Affairs• Support continuous improvement initiatives to strengthen CRO quality standardsRequired QualificationsEducational Requirements:• Doctor of Pharmacy (Pharm.D) – MandatoryExperience and Skills:• 5–10 years of experience in Quality Management Systems or Quality Assurance within the clinical research industry• Strong knowledge of QMS principles and audit practices• Understanding of clinical research processes including clinical trials, pharmacovigilance, and regulatory submissions• Knowledge of regulatory guidelines such as ICH-GCP, CDSCO, USFDA, and EMA• Excellent documentation, analytical, and problem-solving skills• Strong communication and presentation abilities• Ability to manage multiple tasks and maintain strict timelinesSalary Insights:• Salary offered as per company normsBenefits• Health Insurance• Provident FundCompany OverviewForward Life Pvt. Ltd. is a growing Clinical Research Organization providing services in clinical operations, pharmacovigilance, regulatory affairs, and quality management. The organization follows global regulatory standards and focuses on maintaining high-quality research practices across pharmaceutical and healthcare projects.FAQs• What qualification is required for this role?Candidates must hold a Doctor of Pharmacy (Pharm.D) degree.• How much experience is required?Applicants should have 5–10 years of experience in Quality Assurance or Quality Management Systems within the clinical research industry.• Where is the job located?The position is based in Hyderabad, Telangana, India.• What type of work will the candidate perform?The role focuses on QMS implementation, internal audits, compliance monitoring, and regulatory documentation management.Application Tips• Highlight experience with Quality Management Systems and clinical research compliance• Mention experience with audits, CAPA management, and SOP documentation• Showcase knowledge of ICH-GCP and other global regulatory guidelines• Include examples of process improvement and quality assurance initiatives• Demonstrate strong documentation and regulatory compliance skills

Why This Role MattersThe Pharmacovigilance Associate plays a critical role in ensuring patient safety by monitoring and evaluating adverse drug reactions and other safety information. The role contributes to maintaining drug safety standards and regulatory compliance while supporting global pharmacovigilance operations within clinical research and pharmaceutical environments.Job DescriptionThe Pharmacovigilance Associate will support drug safety monitoring activities including collection, processing, and evaluation of adverse drug reaction reports. The role involves working with safety databases, preparing regulatory safety documentation, and collaborating with clinical and regulatory teams to ensure compliance with global pharmacovigilance guidelines.Key Features of the Role• Opportunity to work in pharmacovigilance and drug safety operations• Exposure to global PV regulations including ICH, EMA, FDA, and CDSCO• Involvement in safety case processing and regulatory reporting• Collaboration with clinical research, regulatory affairs, and quality teams• Professional development in clinical research and pharmacovigilanceResponsibilities• Collect and process Individual Case Safety Reports (ICSRs) from healthcare professionals, patients, and literature sources• Perform data entry and medical coding of adverse events using safety databases such as Argus or ARISg• Conduct case assessment, narrative writing, and quality review of safety reports• Support preparation of aggregate safety reports including PBRERs, PSURs, and DSURs• Assist in signal detection, risk assessment, and benefit–risk evaluation activities• Ensure compliance with global pharmacovigilance regulations and guidelines• Collaborate with cross-functional teams including clinical operations, regulatory affairs, and quality assurance• Participate in audits, inspections, and implementation of corrective and preventive actions (CAPA)• Maintain updated knowledge of pharmacovigilance guidelines and regulatory requirementsRequired QualificationsEducational Requirements:• Doctor of Pharmacy (Pharm.D) – MandatoryExperience and Skills:• 0–5 years of experience in pharmacovigilance or drug safety operations• Knowledge of pharmacology, drug safety, and clinical research practices• Understanding of pharmacovigilance guidelines including ICH E2A–E2E and GVP modules• Experience with safety databases such as Argus or ARISg preferred• Strong analytical and documentation skills• Excellent written and verbal communication abilities• Proficiency in Microsoft Office toolsSalary Insights:• Salary offered as per company normsCompany OverviewForward Life Pvt. Ltd. is a growing Clinical Research Organization providing services in clinical operations, pharmacovigilance, regulatory affairs, and quality management. The company operates with global standards and supports pharmaceutical and healthcare organizations in clinical research and regulatory compliance activities.FAQs• What qualification is required for this role?Candidates must have a Doctor of Pharmacy (Pharm.D) degree.• How much experience is required?Candidates with 0–5 years of experience in pharmacovigilance or related fields can apply.• Where is the job located?The role is based in Hyderabad, Telangana, India.• What shift schedule is required?Candidates must be willing to work in rotational shifts and agree to a 2-year employment agreement.Application Tips• Highlight pharmacovigilance internships or experience in drug safety• Mention knowledge of ICSR processing and safety database systems• Include familiarity with global PV guidelines such as ICH and GVP• Showcase analytical and medical writing skills related to safety reporting• Emphasize teamwork and ability to work in regulatory and clinical environments

Why This Role MattersMedical reviewers play a vital role in ensuring the safety of pharmaceutical products throughout their lifecycle. They analyze adverse event reports, review clinical safety data, and ensure that potential risks associated with medications are properly evaluated and documented. The Medical Reviewer – Pharmacovigilance role focuses on reviewing clinical and post-marketing safety cases to identify potential safety signals and ensure accurate medical evaluation of adverse events. This helps pharmaceutical companies maintain high safety standards and protect patient health. Another key aspect of the role is ensuring compliance with global pharmacovigilance regulations and safety reporting standards. Medical reviewers evaluate case narratives, assess causality, and verify the medical accuracy of safety data before submission to regulatory authorities. In addition, they collaborate with drug safety teams, clinical research professionals, and regulatory experts to improve the quality of safety reporting and maintain compliance with international guidelines. Overall, this role combines clinical expertise, drug safety knowledge, and regulatory compliance to support safe pharmaceutical development and monitoring.Job DescriptionThe Medical Reviewer – Pharmacovigilance is responsible for performing medical reviews of adverse event cases from clinical trials, post-marketing surveillance, and literature sources. Professionals in this role assess the medical accuracy of case reports, review clinical narratives, evaluate seriousness criteria, and ensure correct medical coding and classification of adverse events. The role also involves evaluating suspect drugs, concomitant medications, laboratory findings, and patient medical histories to determine potential drug-related safety risks. Additionally, medical reviewers provide medical guidance to pharmacovigilance teams, assist with safety queries, and contribute to regulatory compliance by following global safety reporting timelines and procedures. They also participate in safety discussions, audits, and internal forums to ensure high-quality drug safety monitoring and reporting.Key Features of the Role:• Opportunity to work in pharmacovigilance and drug safety operations.• Involvement in clinical safety case review and medical assessment.• Collaboration with drug safety, regulatory, and clinical research teams.• Exposure to global safety databases and pharmacovigilance systems.• Opportunity to support regulatory compliance and patient safety monitoring.• Role within the business process services division of Tata Consultancy Services.Responsibilities• Perform medical review of clinical, spontaneous, and solicited safety cases.• Conduct medical assessments including labeling review and causality evaluation.• Review adverse event seriousness, medical coding, and case narratives.• Evaluate suspect drugs, concomitant medications, laboratory results, and medical history.• Support drug safety teams with medical expertise and safety awareness.• Respond to queries related to individual case safety reports in safety databases.• Generate and track follow-up queries for additional safety information.• Provide medical input on cases involving Suspected Unexpected Serious Adverse Reactions (SUSAR).• Ensure compliance with global and local pharmacovigilance procedures and regulatory timelines.• Participate in internal safety meetings, audits, and client discussions.Required Qualifications• Strong medical knowledge relevant to pharmacovigilance and drug safety.• Good understanding of adverse event reporting and regulatory processes.• Strong analytical and problem-solving skills.• Excellent interpersonal and communication abilities.• Ability to work in multidisciplinary teams.Educational Requirements• MBBS or equivalent medical qualification.• MD or higher medical qualification is preferred.Experience and Skills• 9 months to 4 years of experience in pharmacovigilance or clinical research.• Experience in drug safety case processing or medical review preferred.• Good understanding of pharmacovigilance regulations and safety reporting.• Proficiency in MS Office and safety database systems.• Ability to analyze clinical data and medical case narratives.Salary InsightsMedical reviewers in India typically earns depending on experience, expertise in pharmacovigilance, and organizational role.Company OverviewTata Consultancy Services (TCS) is one of the largest IT services and consulting companies globally. The organization provides technology-driven services across multiple sectors, including healthcare, life sciences, and pharmacovigilance. Through its Business Process Services division, TCS supports pharmaceutical companies with drug safety operations, regulatory services, and clinical data management.FAQs• Who can apply for this role?Candidates with an MBBS or equivalent medical qualification and experience in pharmacovigilance or clinical research.• Is pharmacovigilance experience mandatory?It is preferred but not always mandatory if the candidate has strong medical knowledge.• What type of work environment is involved?The role involves working with drug safety teams and regulatory professionals in a corporate healthcare services environment.• What is the job location?The position is based in Mumbai.Application Tips• Highlight your pharmacovigilance or clinical research experience in your resume.• Clearly mention drug safety tools or safety database systems you have used.• Emphasize knowledge of adverse event reporting and causality assessment.• Include experience related to clinical case review or medical evaluation.• Ensure your resume highlights strong medical knowledge and analytical skills.

Why This Role MattersMedical information services play a critical role in the pharmaceutical and healthcare industry by ensuring that accurate, evidence-based information about medicines is communicated to healthcare professionals, patients, and other stakeholders. The Medical Information Contact Center (MICC) Associate role supports pharmaceutical companies in providing reliable scientific information about their products while maintaining regulatory compliance and patient safety standards. Healthcare professionals and patients often seek clarification regarding drug usage, dosage, safety information, contraindications, and therapeutic applications. The MICC team acts as the primary point of contact for these inquiries, ensuring that responses are scientifically accurate and aligned with approved medical information resources. This helps maintain transparency, improves patient outcomes, and supports responsible medicine use. For pharmacy graduates, this role provides an excellent entry point into the life sciences industry. It offers exposure to important functional areas such as medical affairs, pharmacovigilance support, medical communication, and drug safety operations. Professionals working in MICC roles develop strong scientific communication skills and gain experience handling global medical information inquiries. Additionally, the role provides practical exposure to medical documentation systems, regulatory guidelines, and pharmacovigilance standards. This experience can help professionals build careers in areas such as pharmacovigilance, medical writing, regulatory affairs, and clinical research. Working in a global medical information contact center environment also helps professionals develop strong communication and analytical skills while interacting with healthcare professionals and international stakeholders. Over time, this experience supports career growth within the pharmaceutical industry’s medical and safety domains.Job DescriptionThe Medical Information Contact Center (MICC) Associate is responsible for responding to medical information inquiries related to pharmaceutical products. The role involves communicating with healthcare professionals, patients, and other stakeholders to provide accurate scientific information while maintaining compliance with medical information guidelines and regulatory requirements. Professionals in this position handle inbound and outbound communications through email and telephonic interactions. They ensure that inquiries are addressed using approved scientific resources and documented properly within medical information databases. The role also involves maintaining detailed documentation of all interactions, ensuring that responses are compliant with pharmacovigilance standards and internal operating procedures. Accurate documentation is essential for maintaining transparency, supporting regulatory audits, and ensuring high-quality medical information delivery. This position requires strong communication skills, scientific knowledge of pharmaceutical products, and the ability to work in a structured environment. Candidates must be comfortable working in US night shifts to support international healthcare clients and global pharmaceutical operations. Overall, the role offers valuable experience in medical communication, pharmaceutical information management, and healthcare documentation, making it a strong starting point for pharmacy graduates interested in medical affairs and pharmacovigilance careers.Key Features of the Role• Entry-level opportunity for pharmacy graduates in the medical information domain.• Exposure to pharmaceutical medical affairs and pharmacovigilance support functions.• Opportunity to interact with healthcare professionals and global stakeholders.• Development of medical communication and documentation skills.• Practical experience with medical information databases and regulatory documentation.• Exposure to global pharmaceutical product information systems.• Opportunity to build a career in pharmacovigilance, medical writing, or medical affairs.• Training in scientific communication and medical information processes.Responsibilities• Respond to medical information inquiries from healthcare professionals, patients, and other stakeholders.• Provide accurate scientific information related to pharmaceutical products.• Document inquiries and responses in medical information databases.• Ensure compliance with medical information guidelines and pharmacovigilance standards.• Communicate professionally through email and telephonic interactions.• Maintain accurate records of all medical information communications.• Ensure high standards of documentation accuracy and regulatory compliance.• Support pharmaceutical companies’ medical affairs teams in handling product-related inquiries.• Maintain confidentiality and professionalism when interacting with healthcare professionals and patients.• Follow established standard operating procedures (SOPs) and regulatory guidelines while responding to inquiries.Required Qualifications• Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm).• Fresh graduates are eligible to apply.• Strong understanding of pharmaceutical sciences and drug information concepts.Educational Requirements• B.Pharm• M.PharmExperience and Skills• Excellent English communication skills (written and verbal).• Strong understanding of pharmaceutical concepts and drug information.• Ability to document medical information accurately.• Good analytical and problem-solving abilities.• Ability to interact professionally with healthcare professionals.• Strong attention to detail and documentation accuracy.• Willingness to work in US night shifts to support global operations.Salary InsightsThe estimated salary range for entry-level Medical Information Contact Center roles in India typically ranges between ₹3,00,000 and ₹5,00,000 per year depending on the organization, location, and candidate skills. Employees may also receive professional training programs, exposure to global pharmaceutical clients, and career development opportunities within medical affairs and pharmacovigilance functions.Company OverviewAPCER Life Sciences is a global life sciences organization providing specialized services in pharmacovigilance, medical information, regulatory affairs, and risk management. The company works with pharmaceutical, biotechnology, and healthcare organizations to support drug safety monitoring, regulatory compliance, and medical communication. The organization focuses on delivering high-quality scientific and regulatory services that help pharmaceutical companies maintain safety standards and comply with global regulatory requirements. Through its expertise in drug safety and medical information management, the company supports the safe use of medicines worldwide.FAQs• Who can apply for this role?Candidates with B.Pharm or M.Pharm degrees are eligible to apply.• Is prior experience required?No. The role is specifically designed for fresh graduates.• What type of shift is required?The role operates in US night shifts to support international clients.• What career opportunities can this role lead to?Professionals can progress to roles in pharmacovigilance, medical writing, regulatory affairs, or medical affairs.Application Tips• Highlight strong English communication and scientific writing skills.• Demonstrate knowledge of pharmacology and pharmaceutical products.• Mention any training or coursework related to pharmacovigilance or drug safety.• Emphasize documentation accuracy and attention to detail.• Prepare to demonstrate communication skills during the interview process.

Why This Role MattersThe Medical Information Contact Centre Associate plays an essential role in safeguarding patient health and ensuring the safe use of pharmaceutical products. By handling medical inquiries, documenting adverse events, and supporting pharmacovigilance processes, professionals in this role contribute directly to global drug safety monitoring systems. The position acts as an important bridge between pharmaceutical companies, healthcare professionals, patients, and regulatory authorities by ensuring accurate communication and documentation of safety-related information. In the modern pharmaceutical and life sciences industry, pharmacovigilance and medical information functions are increasingly critical. With rising regulatory requirements and a stronger emphasis on patient safety, companies must maintain robust systems for adverse event reporting, product complaint management, and medical communication. This role ensures that safety signals are captured early, documented correctly, and escalated when necessary. Additionally, working in a contact centre environment develops strong communication, documentation, and analytical skills. Professionals interact with healthcare professionals, patients, and consumers, ensuring that medical information is delivered clearly and accurately while maintaining strict regulatory compliance.Job DescriptionThe Medical Information Contact Centre Associate is responsible for handling inbound and outbound communications related to pharmaceutical products. The role involves responding to medical inquiries, documenting adverse events and product complaints, and ensuring proper pharmacovigilance case intake according to established regulatory standards. Professionals in this position work closely with pharmacovigilance teams to ensure that safety information received through calls, emails, or web-based inquiries is captured accurately and documented according to Good Pharmacovigilance Practices (GVP). The role requires strong attention to detail, effective communication skills, and the ability to follow standard operating procedures (SOPs) in a highly regulated environment. The position is based in Hyderabad and operates in a UK/US shift environment. This ensures global coverage for safety reporting and medical information services. Candidates must be comfortable working in an office-based setting and interacting with healthcare professionals, patients, and consumers across international markets. This opportunity is particularly suitable for fresh graduates who want to start their careers in pharmacovigilance, drug safety operations, or medical information services. It offers hands-on exposure to safety case intake processes, customer communication in the healthcare industry, and regulatory compliance standards.Key Features of the Role• Entry-level opportunity in pharmacovigilance and medical information services.• Exposure to adverse event reporting and drug safety case documentation.• Interaction with healthcare professionals, patients, and consumers.• Opportunity to work with global safety teams and international pharmacovigilance regulations.• Development of communication and customer handling skills in the pharmaceutical industry.• Experience with Good Pharmacovigilance Practices (GVP) and SOP-driven processes.• Structured environment that supports learning and career development in drug safety.• Opportunity to gain expertise in adverse event management, product complaints, and safety communication.• Exposure to compliance activities, audits, and regulatory safety documentation.• Career progression opportunities within pharmacovigilance and medical affairs functions.ResponsibilitiesThe Medical Information Contact Centre Associate will be responsible for several operational and safety-related activities within the pharmacovigilance framework.• Handle inbound and outbound calls, emails, and web-based inquiries related to pharmaceutical products.• Document adverse events (AEs), product complaints (PCs), and medical inquiries received from healthcare professionals and consumers.• Process both spontaneous and solicited safety reports in accordance with regulatory guidelines.• Capture information related to adverse drug reactions, medication errors, and special safety cases.• Provide accurate responses to medical information requests using approved knowledge databases and SOP guidelines.• Ensure that medical inquiries are responded to within defined service timelines.• Maintain accurate documentation of calls and safety information according to Good Pharmacovigilance Practices (GVP).• Record adverse event information and ensure correct case intake procedures are followed.• Conduct follow-up communication with healthcare professionals, patients, or consumers to gather additional safety information.• Address and resolve product-related complaints while maintaining compliance with internal policies.• Maintain operational trackers, dashboards, and reporting systems used for monitoring safety communications.• Escalate potential safety concerns or compliance issues to pharmacovigilance teams when required.• Participate in internal audits, compliance checks, and quality assurance activities.• Assist in client meetings and support discussions related to safety operations.• Contribute to the development and improvement of SOPs, training manuals, and operational workflows.• Maintain confidentiality and data protection standards while handling sensitive patient information.Required QualificationsCandidates applying for this role should possess relevant academic qualifications in pharmacy, life sciences, or related healthcare disciplines.Preferred qualifications include: • Bachelor of Pharmacy (B.Pharm)• Master of Pharmacy (M.Pharm)• Doctor of Pharmacy (Pharm.D)• Bachelor of Science or Master of Science in Life SciencesFresh graduates and entry-level candidates are encouraged to apply. Candidates with prior exposure to pharmacovigilance or medical information processes will have an advantage.Educational Requirements• Degree in pharmacy, life sciences, or related healthcare discipline.• Academic background that includes pharmacology, drug safety, or medical communication topics is beneficial.Experience and SkillsCandidates should possess a combination of technical knowledge, communication skills, and attention to detail.Key skills include:• Basic understanding of adverse event reporting processes.• Knowledge of pharmacovigilance concepts and drug safety monitoring.• Familiarity with product complaint handling procedures.• Understanding of Good Pharmacovigilance Practices (GVP).• Strong verbal and written communication skills.• Ability to communicate effectively with healthcare professionals and consumers.• Strong documentation and data entry skills.• Ability to work in SOP-driven environments and maintain regulatory compliance.• Problem-solving and analytical abilities for identifying safety concerns.• Capability to work in a fast-paced contact centre environment.• Willingness to work in UK/US shifts and collaborate with global teams.• Proficiency in Microsoft Office tools such as Word, Excel, and Outlook.Salary InsightsSalary for entry-level pharmacovigilance roles typically varies depending on company policies, candidate qualifications, and experience levels. Fresh graduates entering medical information or pharmacovigilance contact centre roles can expect competitive entry-level packages along with opportunities for career growth. With experience and skill development, professionals can advance to higher roles within pharmacovigilance and drug safety operations.Company OverviewThis opportunity is offered within the pharmaceutical safety and medical information services sector, supporting global pharmacovigilance operations. Organizations operating in this domain provide essential services such as adverse event monitoring, safety case processing, medical communication, and regulatory compliance support for pharmaceutical and biotechnology companies. These organizations play a vital role in ensuring that medicines remain safe for patients by identifying potential safety signals, monitoring adverse events, and supporting regulatory reporting systems worldwide.FAQs• Who can apply for this role?Fresh graduates or entry-level candidates with degrees in pharmacy or life sciences can apply.• Is prior pharmacovigilance experience required?No. This role is suitable for freshers, although basic knowledge of pharmacovigilance concepts is helpful.• What type of work schedule is required?The role operates in UK/US shift timings to support global safety operations.• Where is the job located?The position is based in Hyderabad and is office-based.• What career growth opportunities are available?Professionals can progress into roles such as Drug Safety Associate, Pharmacovigilance Specialist, Safety Scientist, or Medical Information Specialist.Application Tips• Highlight coursework or training related to pharmacology, pharmacovigilance, or drug safety.• Emphasize strong communication and customer interaction skills.• Demonstrate knowledge of adverse event reporting and product complaint handling.• Showcase attention to detail and ability to maintain accurate documentation.• Mention any internships or academic projects related to pharmaceutical safety or medical communication.• Prepare to discuss pharmacovigilance concepts such as adverse event reporting, signal detection, and safety monitoring during interviews.

Why This Role MattersThe Safety & Pharmacovigilance Specialist I plays an important role in maintaining patient safety and regulatory compliance by managing Individual Case Safety Reports (ICSRs), handling Product Quality Complaints (PQC), and supporting global pharmacovigilance reporting activities. This role contributes to ensuring that safety data is accurately captured, evaluated, and reported in compliance with international regulations, ultimately helping protect patients and support the safe use of therapies worldwide.Job DescriptionThe Safety & PV Specialist I is responsible for end-to-end pharmacovigilance case processing, safety data management, and regulatory reporting support. The role involves managing ICSRs, performing quality reviews, coding medical data using MedDRA, preparing narratives, and supporting safety compliance activities. The position also includes literature screening, audit support, and collaboration with global teams to ensure adherence to regulatory standards and safety procedures.Key Features of the Role• Manage end-to-end ICSR processing and safety case management.• Enter and track safety information within pharmacovigilance databases.• Perform case triage to evaluate completeness and regulatory reportability.• Code adverse events, medications, and medical history using MedDRA and related dictionaries.• Prepare medically accurate narrative summaries for safety cases.• Identify missing or inconsistent information and follow up for resolution.• Perform quality review of ICSRs and manage duplicate case identification.• Support preparation and submission of expedited regulatory safety reports.• Maintain safety documentation in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).• Support xEVMPD product record validation and SPOR/IDMP-related activities.• Conduct literature screening and safety monitoring activities.• Participate in audits and support inspection readiness.• Maintain compliance with SOPs, GCP, ICH guidelines, GVP, and global safety regulations.Responsibilities• Process and manage Individual Case Safety Reports (ICSRs).• Perform coding of medical data using MedDRA and maintain drug dictionaries.• Prepare narrative summaries and evaluate safety case completeness.• Assist in regulatory safety reporting and global compliance activities.• Manage Product Quality Complaint (PQC) safety cases.• Maintain pharmacovigilance documentation and regulatory records.• Collaborate with internal and external stakeholders to support safety operations.Required Qualifications• B.Pharm / M.Pharm / PharmD / BDS / BMS / MBBS• Minimum 2.5–4 years of experience in pharmacovigilance or drug safety roles• At least 1 year of exclusive experience handling Product Quality Complaint (PQC) cases• Hands-on experience with safety databases such as Argus or ARISg• Knowledge of global pharmacovigilance regulations and reporting requirementsEducational Requirements• Bachelor’s or Master’s degree in pharmacy, medicine, dentistry, or related healthcare fieldExperience and Skills• Strong experience in ICSR processing and pharmacovigilance case management• Knowledge of MedDRA coding and safety data evaluation• Understanding of clinical trial phases II–IV and post-marketing safety surveillance• Familiarity with regulatory safety reporting requirements• Experience with pharmacovigilance databases such as Argus or ARISg• Strong analytical, communication, and documentation skills• Ability to work with cross-functional global teamsSalary Insights• Salary not specified; compensation is typically aligned with industry standards for pharmacovigilance specialists in India.Company OverviewSyneos Health is a global biopharmaceutical solutions organization providing clinical, medical affairs, and commercial services to accelerate the development and commercialization of therapies. The company operates across more than 110 countries and collaborates with leading pharmaceutical and biotechnology organizations to bring innovative treatments to patients worldwide.FAQs• Where is the job location?Gurugram, Haryana, India.• What experience is required?2.5–4 years in pharmacovigilance, including Product Quality Complaint (PQC) case handling.• Which safety databases are required?Experience with Argus or ARISg safety databases.• Is clinical trial safety experience required?Yes, knowledge of clinical trial safety (Phases II–IV) or post-marketing pharmacovigilance is preferred.Application Tips• Highlight experience in ICSR processing and pharmacovigilance workflows.• Emphasize knowledge of MedDRA coding and global safety reporting requirements.• Mention hands-on experience with safety databases such as Argus or ARISg.• Showcase experience managing Product Quality Complaint (PQC) cases.• Include examples of audit participation, regulatory submissions, or compliance support.

Why This Role MattersThe Vigilance Specialist plays a critical role in ensuring patient safety and regulatory compliance by managing complaints, monitoring product incidents, and supporting post-market surveillance activities. This role ensures that all vigilance processes meet regulatory standards while helping the organization maintain high-quality medical device safety across global markets.Job DescriptionThe Vigilance Specialist will be responsible for end-to-end complaint and incident management for products placed on the market. The role involves evaluating reported events, preparing regulatory submissions, supporting product risk management activities, and coordinating with global stakeholders to ensure compliance with vigilance regulations and internal SOPs.Key Features of the Role• Receive, record, evaluate, investigate, and process complaints related to marketed products.• Manage complaint case flow to ensure timely processing and compliance with regulatory deadlines.• Perform medical and technical evaluation of reported product incidents.• Maintain complete and accurate documentation in vigilance and complaint management systems.• Prepare vigilance data to support product risk management activities.• Generate vigilance reports to support global product registrations and renewals.• Prepare vigilance-related data for Clinical Evaluation Reports, Technical Files, and regulatory documentation.• Submit medical device incident reports to regulatory authorities worldwide.• Ensure compliance with internal SOPs and external regulatory requirements.• Support training and awareness of vigilance processes for internal teams and distribution partners.• Assist in developing and updating SOPs, work instructions, and training materials related to vigilance.• Participate in internal and external audits and regulatory inspections.• Act as a liaison between regional teams, distributors, and global headquarters.• Support the Vigilance Manager in tracking regulatory and legislative updates.Responsibilities• Manage complaint intake, investigation, and documentation processes.• Conduct technical and medical assessments of reported events.• Prepare and submit regulatory vigilance reports to health authorities.• Support product risk management and post-market surveillance activities.• Maintain regulatory compliance across global markets.• Collaborate with cross-functional teams to ensure effective vigilance processes.Required Qualifications• Bachelor’s degree in Life Sciences, Clinical Sciences, Engineering, or related field.• Postgraduate qualification in Pharmacovigilance, Medical Device Vigilance, or Regulatory Affairs is an advantage.• 3–6 years of experience in vigilance, pharmacovigilance, or medical device post-market surveillance.Educational Requirements• Bachelor’s degree in life sciences, clinical sciences, engineering, or related field.• Additional specialization in pharmacovigilance or regulatory affairs preferred.Experience and Skills• Knowledge of medical device vigilance systems and regulatory requirements.• Experience handling global markets and multiple regulatory authorities.• Strong analytical skills for evaluating complaints and incidents.• Ability to prepare regulatory documentation and vigilance reports.• Excellent communication and collaboration skills for working with global teams.• Experience with post-market surveillance and risk management processes.• Prior experience with ophthalmic products is highly preferred.Salary Insights• Salary details are not specified and will be discussed during the recruitment process.Company OverviewRayner is a global leader in ophthalmic medical devices, dedicated to improving vision and enhancing the quality of life for millions of people worldwide through innovative eye care solutions.FAQs• Where is the job location?Ahmedabad, India.• What type of role is this?Permanent full-time position in Regulatory Affairs/Vigilance.• What experience is required?3–6 years in vigilance, pharmacovigilance, or medical device post-market surveillance.• Is global collaboration involved?Yes, the role involves coordination with global teams and regulatory authorities.Application Tips• Highlight experience in pharmacovigilance, medical device vigilance, or post-market surveillance.• Demonstrate knowledge of regulatory reporting and global compliance requirements.• Emphasize your ability to handle complaint investigations and incident evaluations.• Showcase collaboration experience with cross-functional and international teams.• Include examples of regulatory submissions, vigilance reporting, or audit participation.

Why This Role MattersThe Associate, Drug Safety – Quality, Standards & Training ensures the consistent application of pharmacovigilance (PV) standards and quality systems across Azurity Pharmaceuticals. By supporting SOP management, training, audits, and inspection readiness, this role helps maintain regulatory compliance, enhances process reliability, and protects patient safety across the organization’s global operations.Job DescriptionThis associate-level position, based in Hyderabad, reports to the Manager, Drug Safety Compliance. The role involves supporting drug safety quality systems, coordinating training programs, maintaining SOPs and documentation, and assisting in regulatory inspections and audits. The Associate works closely with cross-functional teams to ensure compliance, process standardization, and continuous improvement within the Global Drug Safety organization.Key Features of the Role• Support the administration and maintenance of Drug Safety SOPs, work instructions, and standards.• Coordinate onboarding and refresher training programs for Drug Safety personnel.• Track training completion, maintain records, and report compliance metrics.• Assist with preparation for regulatory inspections and internal/external audits.• Maintain inspection-ready documentation and training records.• Partner with Operations, Compliance, Quality, Regulatory Affairs, and Clinical teams to ensure standards are consistently applied.• Serve as a communication point for quality- and training-related initiatives within Drug Safety.• Support global initiatives requiring standardized processes and training support.Responsibilities• Maintain and update Drug Safety SOPs, work instructions, and related documentation.• Coordinate and support Drug Safety training programs for staff, including compliance tracking.• Assist in preparing for audits and inspections by organizing relevant documentation.• Support the implementation and adherence to quality standards and procedures.• Facilitate communication between Drug Safety, Compliance, Quality, and other departments.• Support continuous improvement initiatives and standardized global processes.Required Qualifications• 1–3 years of experience in pharmacovigilance, quality, compliance, training, or related pharmaceutical/regulated healthcare roles.• Experience with quality systems, SOP management, and training coordination preferred.• Understanding of pharmacovigilance and regulated quality environments.Educational Requirements• Bachelor’s degree in Life Sciences, Healthcare, Quality, Training, or related field.Experience and Skills• Familiarity with global pharmacovigilance regulations and compliance standards.• Strong organizational, documentation, and communication skills.• Ability to work collaboratively across cross-functional teams.• Attention to detail and commitment to regulatory compliance and quality standards.Salary Insights• Compensation as per company standards; details discussed during recruitment.Company OverviewAzurity Pharmaceuticals is a privately held specialty pharmaceutical company delivering innovative medicines for underserved patients. Its global portfolio spans cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets. Azurity is committed to patient-centric solutions, high-quality products, and inclusive workplace culture.FAQs• Who can apply?Candidates with experience in pharmacovigilance, quality, compliance, or training roles within pharmaceutical or regulated healthcare environments.• Is this role office-based or remote?Based in Hyderabad, working within the Drug Safety Compliance team.• What departments will the Associate collaborate with?Drug Safety Operations, Compliance, Quality, Regulatory Affairs, and Clinical teams.• Are audits and inspections part of the role?Yes, supporting preparation and documentation for internal and regulatory inspections is required.Application Tips• Highlight experience in pharmacovigilance, quality systems, and SOP management.• Emphasize prior training coordination or compliance-related work.• Demonstrate familiarity with regulatory requirements and inspection readiness.• Showcase strong organizational and communication skills.• Include examples of collaboration with cross-functional teams and continuous improvement initiatives.

Why This Role MattersPharmacovigilance professionals play an essential role in safeguarding patient health by monitoring the safety of medicines and ensuring timely reporting of adverse events. Accurate safety data collection, evaluation, and reporting are crucial to maintaining regulatory compliance and protecting patients worldwide.The Japan Local Case Advisor role at AstraZeneca is particularly important because it focuses on managing safety reports related to products used in the Japanese market. The position supports Individual Case Safety Report processing, adverse event reporting, and compliance with Japanese pharmacovigilance regulations.Working within the Global Business Services Patient Safety team, the role involves collaborating with global safety teams while ensuring that local Japanese regulatory requirements are met. This includes managing safety cases, performing data entry into safety databases, and supporting pharmacovigilance compliance activities. For professionals with pharmacovigilance experience and Japanese language proficiency, this role provides a unique opportunity to contribute to global drug safety programs while supporting patient safety initiatives for important therapeutic products.Job DescriptionAstraZeneca is seeking a Japan Local Case Advisor to support pharmacovigilance operations within the Global Business Services Patient Safety function.The selected candidate will be responsible for managing Individual Case Safety Reports and supporting safety reporting activities related to AstraZeneca and Rare Disease Unit products in Japan. The role requires proficiency in English and Japanese and involves collaboration with internal safety teams to ensure timely and accurate safety data processing. This position involves case intake activities, safety database data entry, regulatory compliance monitoring, and support for audits and inspections. The role also contributes to maintaining pharmacovigilance quality systems and ensuring adherence to Japanese regulatory standards.Key Features of the RoleOpportunity to work in global pharmacovigilance and patient safety operationsExposure to safety reporting for the Japanese pharmaceutical marketInvolvement in Individual Case Safety Report management and adverse event reportingCollaboration with multinational teams in a global pharmaceutical environmentParticipation in pharmacovigilance quality systems and compliance activitiesOpportunity to contribute to safety monitoring for innovative medicinesResponsibilitiesCase Intake and Safety ReportingAccept and validate safety reports for domestic cases in Japan and conduct preliminary case assessments. Communicate with reporters when necessary to collect additional safety information and ensure the accuracy of safety reports. Ensure proper handling of personal and confidential information in accordance with regulatory requirements and company policies. Perform routine quality checks and initiate follow-up activities when additional information is required. Collaborate with internal teams to clarify case details, triage incoming safety reports, and escalate urgent or reportable cases for further investigation.Safety Data Entry and Case ManagementEnter safety data accurately into pharmacovigilance databases and ensure that all relevant information is documented correctly. Work with internal teams to resolve data entry issues and ensure high-quality safety documentation. Initiate follow-up requests using product or event-specific questionnaires to obtain additional safety information when required.Audit and Inspection SupportMaintain pharmacovigilance documentation in accordance with internal procedures and regulatory requirements. Support internal and external audits and assist with regulatory authority inspections by ensuring inspection-ready documentation.Regulatory ComplianceEnsure compliance with Japanese regulatory standards for Individual Case Safety Reports and adverse event reporting. Identify urgent or high-risk cases and escalate them according to established safety procedures.Quality Management System SupportContribute to the effective implementation of the pharmacovigilance Quality Management System and maintain awareness of regulatory changes related to the Japanese pharmaceutical market.General ResponsibilitiesPerform peer reviews of safety cases and support additional pharmacovigilance projects when required. Collaborate with internal teams on pharmacovigilance aspects related to organized data collection programs.Required QualificationsEducational RequirementsBachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific field.Experience and Skills1 to 2 years of experience working with safety databases or pharmacovigilance data entry. Strong attention to detail and the ability to identify sensitive personal or confidential information in safety reports. Experience working collaboratively with cross-functional teams and the ability to resolve operational issues effectively.Language RequirementsJapanese language proficiency at N2 level or higher for listening, writing, and speaking. Reading proficiency in Japanese medical terminology and Kanji characters at N3 to N1 level. English language proficiency equivalent to A2 level according to the CEFR framework.Technical KnowledgeFamiliarity with pharmacovigilance processes and adverse event reporting standards. Experience with safety databases such as Oracle Argus Safety is preferred. Knowledge of global pharmacovigilance guidelines such as Good Pharmacovigilance Practice and Good Clinical Practice is considered advantageous. Understanding of medical coding systems such as MedDRA and WHO Drug Dictionary is beneficial.Professional SkillsStrong problem-solving and analytical abilities. Excellent written and verbal communication skills. Ability to work effectively in multicultural teams and collaborate with stakeholders across different regions.Salary InsightsAlthough the exact salary package has not been disclosed, pharmacovigilance roles within global pharmaceutical companies typically offer competitive compensation based on experience, skills, and regional policies. Employees may also benefit from professional development opportunities, exposure to global pharmacovigilance operations, and participation in international patient safety initiatives.Company OverviewAstraZeneca is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines that transform patient care. The company operates across multiple therapeutic areas including oncology, cardiovascular diseases, respiratory conditions, and rare diseases. AstraZeneca places strong emphasis on patient safety and regulatory compliance, supported by advanced pharmacovigilance systems and global safety monitoring programs. Through collaborative research, advanced technology, and strong global partnerships, AstraZeneca continues to develop life-changing medicines while maintaining high standards of quality and safety.FAQsWho can apply for this role?Candidates with a life sciences background and pharmacovigilance experience, along with Japanese language proficiency.Is Japanese language proficiency mandatory?Yes. Japanese language skills at N2 level or higher are required for handling domestic safety cases in Japan.What type of work does the Japan Local Case Advisor perform?The role involves case intake, safety data entry, adverse event reporting, regulatory compliance monitoring, and audit support.Is experience with safety databases required?Experience with pharmacovigilance safety databases such as Argus is preferred.Application TipsHighlight your pharmacovigilance or safety data management experience in your resume.Mention your proficiency in Japanese language and experience working with Japanese regulatory requirements.Include experience with safety databases and adverse event reporting systems.Demonstrate your attention to detail and ability to handle confidential information responsibly.Showcase your ability to collaborate with global teams and manage safety case documentation accurately.

Why This Role MattersMedical coding is a critical component of pharmacovigilance and clinical data management. Accurate coding of medical information ensures that adverse events, medical histories, and drug-related conditions are standardized using globally recognized medical dictionaries. This process enables reliable safety data analysis, signal detection, and regulatory reporting in clinical trials and post-marketing pharmacovigilance programs.The Medical Coder - Pharmacovigilance role focuses on coding clinical and safety data using standardized terminology systems such as MedDRA and ATC classifications. By ensuring consistency in medical coding across clinical databases, professionals in this role help maintain the integrity and reliability of clinical trial data.This position plays an important role in supporting pharmacovigilance operations, clinical data standardization, and safety monitoring activities. For professionals with experience in medical coding, clinical data management, or pharmacovigilance operations, the role offers an opportunity to work on global clinical research projects while contributing to drug safety and regulatory compliance.Job DescriptionVeeda Lifesciences is seeking a Medical Coder to support pharmacovigilance and clinical data management activities in a remote working environment.The selected candidate will be responsible for performing medical coding of adverse events, medical conditions, and drug-related information using standardized medical dictionaries. The role involves collaboration with clinical data managers, pharmacovigilance teams, and clinical scientists to ensure accurate and consistent coding across clinical study databases. The Medical Coder will also contribute to documentation, reporting, and training activities while ensuring that coding processes comply with internal procedures and industry standards.Key Features of the Role• Opportunity to work in pharmacovigilance and clinical data coding• Remote work environment with global project exposure• Involvement in adverse event and medical terminology coding• Collaboration with pharmacovigilance and clinical data management teams• Exposure to electronic data capture systems used in clinical trials• Opportunity to contribute to coding process improvements and training initiativesResponsibilitiesMedical Coding Activities• Perform medical coding for adverse events, medical history, and medical conditions using standardized terminology systems• Apply MedDRA coding for safety-related clinical data• Use ATC classification coding for drug-related information• Ensure coding activities follow approved medical dictionaries and sponsor guidelines• Maintain consistency and accuracy of coded terms across clinical study databasesClinical Data Management Support• Collaborate with clinical data managers, pharmacovigilance teams, and clinical scientists• Raise queries in electronic Case Report Forms or EDC systems for coding discrepancies• Review sponsor feedback and update coded medical terms accordingly• Ensure coding activities align with clinical data management standardsReporting and Documentation• Prepare medical coding reports and performance metrics• Monitor coding backlog and ensure timely completion of assigned tasks• Maintain documentation related to coding activities in accordance with SOPs and regulatory standardsTraining and Team Collaboration• Develop training materials related to medical coding activities• Provide on-the-job training and guidance for new team members• Participate in departmental meetings to improve coding workflows and best practicesRequired QualificationsEducational Requirements• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related healthcare fields• B.Pharm, M.Pharm, Pharm.D, or equivalent qualification preferredExperience and Skills• 2 to 4 years of experience in medical coding within pharmaceutical companies or CROs• Experience working with pharmacovigilance or clinical data management teams• Strong understanding of medical terminology and coding standards• Knowledge of clinical trial data management processes• Strong attention to detail and accuracy in coding activities• Excellent documentation and communication skillsTechnical Skills• MedDRA coding for adverse event classification• ATC coding for drug classification• Experience using electronic data capture systems such as Medidata Rave, Oracle Inform, or similar platforms• Familiarity with clinical database management and data review processesSalary InsightsAlthough the exact salary is not specified, Medical Coding roles in pharmacovigilance and clinical data management typically offer competitive compensation depending on experience, technical expertise, and project responsibilities. Additional benefits may include remote work flexibility, exposure to global clinical research projects, and professional growth opportunities in pharmacovigilance and data management.Company OverviewVeeda Lifesciences is a global clinical research organization providing services across clinical trials, bioequivalence studies, pharmacovigilance, and clinical data management. The organization supports pharmaceutical and biotechnology companies in developing safe and effective therapies through high-quality research and regulatory-compliant processes. With a strong focus on clinical research excellence and regulatory compliance, Veeda Lifesciences contributes to global drug development programs while ensuring patient safety and data integrity across clinical studies.FAQsWho can apply for this role?Candidates with Pharmacy or Life Sciences degrees such as B.Pharm, M.Pharm, Pharm.D, or related qualifications with experience in medical coding.What experience is required for this position?Applicants should have 2 to 4 years of experience in medical coding within pharmaceutical companies or CROs.Which coding systems are used in this role?The role primarily uses MedDRA coding for adverse events and ATC classification coding for drug-related data.Is experience with clinical data systems required?Yes. Experience with EDC systems such as Medidata Rave, Oracle Inform, or similar clinical trial platforms is preferred.Is this a remote position?Yes. The Medical Coder role is offered in a remote working mode.Application Tips• Highlight experience with MedDRA and ATC coding systems• Mention experience working in pharmacovigilance or clinical data management teams• Demonstrate familiarity with EDC platforms such as Medidata Rave or Oracle Inform• Showcase accuracy and attention to detail in medical coding tasks• Emphasize collaboration with clinical data managers and pharmacovigilance professionals

Why This Role MattersCorrective and Preventive Action (CAPA) management is a vital component of quality and compliance systems in pharmacovigilance and regulatory operations. CAPA processes ensure that safety, compliance, and operational issues are systematically investigated, resolved, and prevented from recurring.The CAPA Manager role at Tata Consultancy Services plays an important role in maintaining pharmacovigilance quality standards. The position focuses on identifying root causes of issues, implementing corrective actions, and ensuring regulatory compliance across drug safety operations.This role contributes to improving pharmacovigilance processes, supporting regulatory inspections, and strengthening compliance with global safety regulations. Professionals working in CAPA management help organizations maintain strong quality systems and ensure that safety operations meet global regulatory expectations. For candidates with experience in pharmacovigilance quality systems, audits, and SOP documentation, this role offers the opportunity to work in a structured regulatory environment while collaborating with multiple stakeholders.Job DescriptionTata Consultancy Services is hiring a CAPA Manager to support pharmacovigilance quality and compliance activities within its Business Process Services division. The selected candidate will be responsible for identifying issues, conducting root cause analyses, and developing corrective and preventive action plans to ensure regulatory compliance and operational improvement. The role involves collaboration with cross-functional teams, client interaction, and oversight of CAPA implementation and effectiveness. The CAPA Manager will also support audits, inspections, and continuous improvement initiatives by maintaining accurate documentation and ensuring compliance with regulatory standards.Key Features of the Role• Opportunity to work in pharmacovigilance quality and compliance management• Exposure to global regulatory frameworks and drug safety standards• Involvement in CAPA development, implementation, and monitoring• Participation in audit and inspection readiness activities• Collaboration with cross-functional teams and external stakeholders• Opportunity to contribute to continuous improvement in pharmacovigilance processesResponsibilitiesIssue Detection and Initiation• Identify triggers requiring root cause analysis such as audit findings, deviations, operational issues, or regulatory inquiries• Ensure issues are documented and escalated appropriately for investigationRoot Cause Analysis• Conduct structured root cause analysis using methodologies such as Fishbone diagrams and the Five Whys technique• Analyze relevant data to identify primary and contributing factors responsible for operational or compliance issuesCAPA Planning and Development• Develop corrective and preventive action plans with clear ownership, timelines, and verification metrics• Ensure CAPA plans align with regulatory guidelines, internal procedures, and pharmacovigilance standardsStakeholder Engagement• Collaborate with cross-functional teams to gather insights and ensure complete root cause visibility• Facilitate discussions with relevant departments to coordinate CAPA planning and monitoringClient and Regulatory Interface• Present root cause findings and CAPA proposals during client or regulatory review meetings• Address feedback and ensure alignment with regulatory expectationsImplementation Tracking and Monitoring• Oversee execution of CAPA activities and ensure completion within defined timelines• Track milestones and escalate delays where necessaryEffectiveness Follow-up and CAPA Closure• Conduct effectiveness checks to ensure corrective actions resolve the issue and prevent recurrence• Prepare final CAPA documentation and obtain quality approvals for closureReporting and Continuous Improvement• Generate CAPA dashboards, metrics, and trend reports to track open CAPAs and recurring issues• Identify systemic gaps and recommend improvements to operational processesAudit and Inspection Preparation• Maintain inspection-ready CAPA documentation• Support internal and external audits with required quality recordsRequired QualificationsEducational Requirements• Bachelor’s degree in Life Sciences, Pharmacy, or related fields• B.Pharm, B.Sc, M.Pharm, or M.Sc preferredExperience and Skills• 3 to 8 years of experience in pharmacovigilance quality systems, CAPA management, or regulatory compliance• Experience supporting audits, inspections, and SOP documentation• Strong analytical and root cause investigation skills• Understanding of pharmacovigilance quality processes• Excellent communication and stakeholder management abilities• Ability to manage multiple quality activities and collaborate across teamsTechnical Knowledge• Understanding of pharmacovigilance quality systems and CAPA processes• Familiarity with global regulatory guidelines including ICH Guidelines and Good Pharmacovigilance PracticesSalary InsightsAlthough the exact salary has not been disclosed, CAPA Manager roles in pharmacovigilance and regulatory operations typically offer competitive compensation depending on experience, expertise, and organizational policies.Additional benefits may include professional development opportunities, exposure to global regulatory operations, and career growth within pharmacovigilance quality management.Company OverviewTata Consultancy Services is a leading global IT services, consulting, and business solutions organization. The company provides technology-driven services to organizations across industries including healthcare, pharmaceuticals, and life sciences.Through its Business Process Services division, TCS supports global pharmaceutical companies with pharmacovigilance operations, regulatory compliance, clinical data management, and safety monitoring activities.With a strong focus on innovation and regulatory excellence, the company helps life sciences organizations improve operational efficiency while maintaining high standards of compliance and patient safety.FAQsWho can apply for this role?Candidates with Life Sciences or Pharmacy degrees such as B.Pharm, B.Sc, M.Pharm, or M.Sc and relevant experience in pharmacovigilance or CAPA management.What experience is required for this position?Applicants should have 3 to 8 years of experience in pharmacovigilance quality systems, CAPA processes, audits, or regulatory compliance activities.What skills are important for a CAPA Manager?Key skills include root cause analysis, CAPA planning, audit readiness, regulatory compliance knowledge, and stakeholder communication.Does this role involve working with regulatory guidelines?Yes. The role requires understanding and applying global pharmacovigilance regulations such as ICH guidelines and EU Good Pharmacovigilance Practices.Application Tips• Highlight experience in pharmacovigilance quality systems and CAPA management• Mention involvement in audits, inspections, and SOP documentation• Demonstrate expertise in root cause analysis tools such as Fishbone diagrams and Five Whys• Include examples of successful CAPA implementation and compliance improvements• Emphasize communication and collaboration with cross-functional teams

Why This Role MattersPharmacovigilance systems are critical for monitoring medicine safety across clinical development and post-marketing phases. Effective drug safety management ensures that adverse events are identified, assessed, and reported to global regulatory authorities in compliance with international guidelines.The Pharmacovigilance Manager – Veeva Vault Safety plays an important role in maintaining pharmacovigilance systems and ensuring accurate safety data management. This role focuses on the configuration, management, and optimization of the Veeva Vault Safety platform, which supports global drug safety operations.Professionals in this role contribute to regulatory compliance, risk management, and safety reporting while collaborating with cross-functional teams such as clinical research, regulatory affairs, and IT. By ensuring the reliability of safety systems and processes, the role helps pharmaceutical organizations maintain strong pharmacovigilance operations and protect patient safety.Job DescriptionThe Pharmacovigilance Manager – Veeva Vault Safety is responsible for managing pharmacovigilance systems and ensuring compliance with global drug safety regulations. The role includes overseeing the configuration and maintenance of the Veeva Vault Safety platform, managing safety data workflows, and supporting regulatory reporting requirements.The manager works closely with drug safety teams, regulatory departments, and IT specialists to ensure accurate data management and efficient pharmacovigilance processes. The position also involves safety data analysis, system optimization, and implementation of regulatory updates.Key Features of the Role• Leadership role in pharmacovigilance system management• Hands-on experience with Veeva Vault Safety platform• Involvement in global pharmacovigilance operations• Exposure to regulatory reporting and safety data analytics• Cross-functional collaboration with clinical, regulatory, and IT teams• Opportunity to improve pharmacovigilance systems and workflowsResponsibilitiesPharmacovigilance System Management• Oversee operation and maintenance of the Veeva Vault Safety system• Configure and customize safety systems to meet regulatory and organizational requirements• Implement workflows for adverse event reporting and safety data processing• Monitor system performance and resolve operational issuesSafety Data Management• Manage collection, processing, and analysis of pharmacovigilance data• Generate safety reports for internal stakeholders and regulatory submissions• Ensure integrity, accuracy, and confidentiality of safety data• Maintain pharmacovigilance documentation and system recordsRegulatory Compliance• Ensure system compliance with global pharmacovigilance regulations including FDA, EMA, and ICH guidelines• Prepare and submit periodic safety reports and regulatory documentation• Stay updated on regulatory changes and implement necessary updatesCross-Functional Collaboration• Work closely with clinical, regulatory affairs, and IT teams• Support safety monitoring activities during drug development• Participate in safety review meetings and risk assessment discussions• Contribute to process improvement initiatives in pharmacovigilance operationsRequired QualificationsEducational Requirements• Master of Pharmacy (M.Pharm)• Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or related healthcare fieldExperience and Skills• 5–12 years of experience in Pharmacovigilance or Drug Safety• Strong experience with Veeva Vault Safety or similar pharmacovigilance systems• Knowledge of global pharmacovigilance regulations and reporting requirements• Experience in safety database configuration and workflow management• Strong analytical and problem-solving skills• Proficiency in safety data management and analysis• Excellent communication and interpersonal skills• Ability to work independently and collaboratively within teamsSalary InsightsCompensation for Pharmacovigilance Manager roles varies depending on experience, company size, and geographic location. Professionals with strong expertise in pharmacovigilance systems such as Veeva Vault Safety often receive competitive industry packages, along with benefits such as performance incentives, health insurance, and professional development opportunities.FAQsWho can apply for this role?Candidates with a Master’s degree in Pharmacy, Nursing, Life Sciences, or related healthcare fields and 5–12 years of pharmacovigilance experience.Is Veeva Vault Safety experience mandatory?Hands-on experience with Veeva Vault Safety or similar pharmacovigilance safety systems is highly preferred.What type of work will the PV Manager perform?The role involves pharmacovigilance system management, safety data analysis, adverse event workflow management, and regulatory reporting.What teams will this role collaborate with?The position works closely with clinical development teams, regulatory affairs departments, IT specialists, and global pharmacovigilance teams.Application TipsHighlight your experience with Veeva Vault Safety configuration and workflows. Demonstrate knowledge of global pharmacovigilance regulations such as ICH, FDA, and EMA guidelines. Mention experience managing safety databases and adverse event reporting systems. Emphasize analytical skills and safety data reporting experience. Showcase collaboration with clinical, regulatory, and IT teams involved in drug safety operations.

Why This Role MattersPharmacovigilance is a critical function in the pharmaceutical and biopharmaceutical industry, ensuring that medicines remain safe and effective throughout their lifecycle. From clinical trials to post-marketing surveillance, pharmacovigilance professionals monitor adverse events, analyze safety data, and ensure regulatory compliance with international drug safety standards.The Senior Pharmacovigilance Specialist role at Alvotech is essential in maintaining the safety profile of biosimilar medicines and supporting global safety operations. The position focuses on safety data management for clinical trials and post-marketing programs while ensuring that pharmacovigilance activities meet international regulatory requirements. As part of the Global Safety Data Management team, the Senior PV Specialist will contribute to safety data analysis, adverse event reporting, regulatory submissions, and the development of pharmacovigilance processes and systems. The role also supports safety system lifecycle management and cross-functional collaboration with clinical, regulatory, and quality teams.This position provides experienced pharmacovigilance professionals with the opportunity to work on global drug safety programs while contributing to the development and monitoring of biosimilar medicines.Job DescriptionAlvotech is seeking a skilled Senior Pharmacovigilance Specialist to support clinical safety and post-marketing pharmacovigilance activities within its Research and Development function. The selected candidate will join the Global Safety Data Management team and will be responsible for managing safety data related to clinical trials and marketed products. The role involves overseeing adverse event reporting, maintaining safety databases, ensuring regulatory compliance, and supporting the development of pharmacovigilance systems and processes.The Senior PV Specialist will also collaborate with cross-functional teams across the organization to ensure that safety activities are performed efficiently and in compliance with global pharmacovigilance standards.Key Features of the Role• Opportunity to work in global pharmacovigilance and safety data management• Involvement in clinical trial safety monitoring and post-marketing surveillance• Participation in pharmacovigilance system configuration and lifecycle management• Collaboration with global regulatory, quality, and clinical teams• Contribution to safety process optimization and regulatory compliance initiatives• Exposure to safety monitoring for biosimilar medicinesResponsibilitiesClinical Safety & Pharmacovigilance Activities• Manage assigned clinical safety and post-marketing pharmacovigilance activities• Handle Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) processing• Support regulatory safety submissions and reporting requirements• Conduct literature monitoring and digital platform monitoring for safety signals• Perform pharmacovigilance reconciliations and safety data reviews• Support activities related to EudraVigilance and XEVMPDSafety Systems & Data Management• Participate in configuration, validation, and lifecycle management of pharmacovigilance systems• Maintain and monitor safety databases to ensure data accuracy and regulatory compliance• Work with safety systems such as Oracle Argus Safety, ARISg Safety System, and Veeva Vault SafetyPharmacovigilance Process Management• Create, maintain, and optimize global pharmacovigilance processes• Ensure compliance with international regulatory guidelines and company procedures• Monitor pharmacovigilance activities to maintain regulatory compliance across clinical and post-marketing programsCross-Functional Collaboration• Work closely with pharmacovigilance teams involved in benefit-risk management and clinical trials• Collaborate with departments such as Quality, Regulatory Affairs, IT, and Clinical Program Development• Coordinate with external pharmacovigilance service providers and business partnersTraining, Audits & Compliance• Deliver pharmacovigilance training programs to internal staff and external partners• Participate in safety-related audits and regulatory inspections• Ensure proper documentation and compliance with global pharmacovigilance standardsRequired QualificationsEducational Requirements• Master’s degree in Pharmaceutical Sciences, Pharmacy, Medicine, or Life SciencesExperience and Skills• Minimum 5 years of experience in Pharmacovigilance or Drug Safety• Strong experience in safety data management functions• Hands-on experience in clinical trial safety and post-marketing pharmacovigilance activities• Experience working with global pharmaceutical products and clinical trials• Familiarity with biologic or combination products is considered an advantageTechnical Knowledge• Experience working with pharmacovigilance safety systems such as Oracle Argus Safety, ARISg Safety System, or Veeva Vault Safety• Understanding of global pharmacovigilance regulations including• ICH Guidelines• FDA Regulations• Good Pharmacovigilance Practices• Good Clinical Practice• Council for International Organizations of Medical Sciences safety reporting standardsProfessional Skills• Strong analytical, organizational, and time-management skills• Excellent communication and stakeholder management abilities• Ability to work independently and manage complex pharmacovigilance activities• Comfortable working in global and multicultural teamsSalary InsightsAlthough the salary package has not been specified, Senior Pharmacovigilance Specialist roles in the global biopharmaceutical industry typically offer competitive compensation based on experience, expertise, and geographic location.Additional benefits may include international project exposure, professional development opportunities, and involvement in global clinical safety programs.Company OverviewAlvotech is a global specialty biopharmaceutical company dedicated to developing and manufacturing high-quality biosimilar medicines.The company focuses exclusively on biosimilars with the goal of improving access to biologic treatments while maintaining strict regulatory and quality standards. Within the Research and Development function, the Integrated Clinical and Medical Research department develops clinical strategies aligned with biosimilar regulatory guidelines and health authority requirements. Through advanced safety monitoring systems and global pharmacovigilance operations, Alvotech ensures the safety, effectiveness, and regulatory compliance of its products worldwide.FAQsWho can apply for this role?Candidates with a Master’s degree in Pharmacy, Life Sciences, or Medicine and at least 5 years of pharmacovigilance experience.What type of work does the Senior PV Specialist perform?The role includes adverse event management, safety data analysis, regulatory reporting, safety system management, and pharmacovigilance compliance activities.Is experience with safety databases required?Yes. Experience with systems such as Argus, ARISg, or Veeva Vault Safety is preferred.Does the role involve working with clinical trials?Yes. The position supports safety monitoring for both clinical trials and post-marketing pharmacovigilance programs.Application Tips• Highlight your pharmacovigilance and safety data management experience• Mention expertise in ICSR processing, SAE reporting, and regulatory submissions• Include knowledge of safety databases such as Argus or Veeva Vault Safety• Demonstrate familiarity with global PV regulations such as ICH, GVP, and GCP guidelines• Emphasize strong documentation practices and cross-functional collaboration skills

Why This Role MattersPharmacovigilance plays a critical role in ensuring the safety of medicines throughout their lifecycle, from clinical trials to post-marketing surveillance. Drug safety professionals monitor adverse events, analyze safety data, and ensure compliance with global regulatory standards to protect patient health.The Pharmacovigilance Specialist role at Alvotech provides an excellent opportunity to work in global safety data management within the biopharmaceutical industry. The position supports safety monitoring for clinical trials and post-marketing programs while ensuring adherence to international pharmacovigilance regulations. As part of the Global Safety Data Management team, the specialist will contribute to safety systems, regulatory submissions, and pharmacovigilance process improvements. This role is especially important for biosimilar products, where rigorous safety monitoring and regulatory compliance are essential to ensure patient safety and product reliability.For professionals with pharmacovigilance experience, this role offers exposure to global safety operations, regulatory frameworks, and advanced safety systems used in modern drug safety management.Job DescriptionAlvotech is seeking a Pharmacovigilance Specialist to support clinical safety and post-marketing pharmacovigilance activities within its Research and Development function. The selected candidate will join the Global Safety Data Management team and work closely with safety leaders to ensure accurate management of safety data for clinical trials and marketed products. The role includes monitoring adverse events, managing safety reports, ensuring regulatory compliance, and supporting pharmacovigilance system operations.This position also contributes to developing pharmacovigilance processes, supporting audits and inspections, and collaborating with internal and external stakeholders involved in drug safety and regulatory activities.Key Features of the Role• Work within global pharmacovigilance and safety data management• Exposure to clinical trial safety monitoring and post-marketing surveillance• Involvement in safety system configuration and lifecycle management• Opportunity to collaborate with global regulatory and clinical teams• Participate in pharmacovigilance process development and compliance initiatives• Contribute to safety monitoring for biosimilar pharmaceutical productsResponsibilitiesClinical Safety & Pharmacovigilance Activities• Manage assigned clinical safety and post-marketing pharmacovigilance activities• Handle Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) management• Support regulatory safety submissions and reporting requirements• Conduct literature monitoring and digital platform monitoring for safety signals• Perform pharmacovigilance reconciliations and safety data verification• Support activities related to EudraVigilance and XEVMPDSafety Systems & Data Management• Support configuration, validation, and lifecycle management of pharmacovigilance systems• Maintain safety databases and ensure accurate safety data management• Work with safety systems such as Oracle Argus Safety, ARISg Safety System, and Veeva Vault SafetyPharmacovigilance Process Management• Develop and maintain global pharmacovigilance procedures and workflows• Ensure compliance with international regulatory guidelines and internal SOPs• Monitor safety processes to maintain regulatory compliance across clinical programsCross-Functional Collaboration• Collaborate with pharmacovigilance teams involved in benefit-risk assessment and clinical safety• Work with internal departments such as Quality, Regulatory Affairs, IT, and Clinical Program Development• Coordinate with external pharmacovigilance service providers and business partnersTraining, Audits & Compliance• Deliver pharmacovigilance training to internal staff and external stakeholders• Support safety-related audits and regulatory inspections• Ensure documentation and processes meet global regulatory requirementsRequired QualificationsEducational Requirements• Master’s degree in Pharmaceutical Sciences, Pharmacy, Medicine, or Life SciencesExperience and Skills• Minimum 3 years of experience in Pharmacovigilance or Drug Safety• Experience working in safety data management functions• Hands-on experience in clinical trial safety and post-marketing pharmacovigilance• Knowledge of safety databases such as Argus, ARISg, or Veeva Vault Safety• Experience working with global pharmaceutical products and clinical trials• Familiarity with biologic or combination products is an advantageRegulatory Knowledge• Strong understanding of global pharmacovigilance regulations and guidelines including• ICH Guidelines• FDA Regulations• GVP Guidelines• GCP Guidelines• CIOMS GuidelinesProfessional Skills• Strong organizational and time-management skills• Excellent communication and interpersonal abilities• Ability to work independently and manage multiple safety activities• Capability to collaborate effectively in multicultural and global teamsSalary InsightsAlthough the exact salary has not been disclosed, Pharmacovigilance Specialist roles in the global biopharmaceutical industry typically offer competitive compensation based on experience, expertise, and geographic location. Additional benefits may include international exposure, professional development opportunities, and involvement in global clinical programs for biosimilar medicines.Company OverviewAlvotech is a fully integrated specialty biopharmaceutical company dedicated to the development and manufacturing of high-quality biosimilar medicines.The company focuses on improving patient access to biologic treatments by developing cost-effective biosimilars while maintaining strict regulatory and quality standards. Within its Research and Development division, the Integrated Clinical and Medical Research department develops strategies aligned with global biosimilar guidelines and regulatory authority requirements. Through innovative clinical programs and strong pharmacovigilance systems, Alvotech ensures the safety, effectiveness, and regulatory compliance of its products worldwide.FAQsWho can apply for this role?Candidates with a Master’s degree in Pharmacy, Life Sciences, or Medicine and at least 3 years of pharmacovigilance experience.What type of work will the PV Specialist perform?The role includes clinical safety monitoring, adverse event management, safety data analysis, regulatory submissions, and pharmacovigilance system management.Is experience with safety databases required?Yes. Experience with safety systems such as Argus, ARISg, or Veeva Vault Safety is highly preferred.Does the role involve working with clinical trials?Yes. The role involves safety monitoring for clinical trials and post-marketing programs.Application Tips• Highlight your pharmacovigilance experience and safety data management expertise• Mention experience working with safety databases such as Argus or Veeva Vault Safety• Include knowledge of global PV regulations such as ICH, GVP, and GCP guidelines• Demonstrate experience managing ICSRs, SAE reporting, and safety monitoring• Emphasize your ability to collaborate with global teams and maintain regulatory compliance

Why This Role MattersPharmacovigilance and post-market safety monitoring are essential for protecting consumers and ensuring that healthcare and wellness products remain safe after they reach the market. Safety professionals play a critical role in analyzing adverse event data, identifying potential risks, and ensuring compliance with global regulatory requirements.The Senior Associate – Global Market Vigilance (GMV) position at Unilever within Unilever R&D Bangalore offers an excellent opportunity for experienced pharmacovigilance professionals to contribute to consumer safety initiatives across global markets. Working under the Global Regulatory Affairs function of the Wellbeing Collective, the role focuses on safety data analytics, signal detection, adverse event monitoring, and compliance reporting. By transforming complex safety datasets into actionable insights, the Senior Associate supports proactive risk management and helps ensure that consumer products meet the highest safety standards. This role is particularly important because it supports end-to-end post-market surveillance activities, helping organizations identify emerging safety signals early and take appropriate action to protect consumers worldwide.Job DescriptionUnilever is seeking a Senior Associate – Global Market Vigilance to support pharmacovigilance and safety monitoring activities for products managed by the Wellbeing Collective. The selected candidate will analyze adverse event data, identify safety trends, build dashboards, and support regulatory reporting processes. The role requires strong analytical expertise and hands-on experience working with safety databases such as Veeva Vault Safety. The position also requires collaboration with cross-functional teams across regulatory affairs, R&D, quality assurance, and consumer care to maintain data integrity, regulatory compliance, and proactive safety monitoring.Key Features of the Role• Work within Global Regulatory Affairs and pharmacovigilance operations• Focus on safety data analytics, signal detection, and trend monitoring• Use advanced safety databases such as Veeva Vault Safety• Collaborate with cross-functional teams including R&D, Quality, and Regulatory Affairs• Contribute to global post-market surveillance and consumer safety programs• Opportunity to mentor junior team members and support analytics initiativesResponsibilitiesSafety Data Analytics, Trending & Signal Detection• Lead trending and signal detection activities across global adverse event datasets• Conduct quantitative and qualitative analysis of safety data to identify emerging risks• Develop dashboards, safety scorecards, and trend reports for stakeholders• Use statistical and analytical tools to generate predictive insights and early warning indicators• Support signal validation and risk assessment for potential safety concerns• Collaborate with analytics teams to improve data automation and visualizationCase Management & Compliance• Manage intake, triage, and documentation of adverse event complaints using Veeva Vault Safety• Perform causality and seriousness assessments for safety events• Ensure timely escalation of potential serious adverse events• Conduct duplicate checks and maintain data quality reviews• Maintain compliance with global adverse event reporting standards and internal SOPsSystem & Process Optimization• Support configuration and validation of safety database updates• Recommend improvements to enhance safety analytics readiness and data accuracy• Conduct audits and reconciliation of safety dataCross-functional Collaboration & Leadership• Act as a point of contact for Regulatory Affairs, R&D, Quality, and customer experience teams• Present safety insights and risk indicators in cross-functional meetings• Mentor junior team members on analytics methods and case processing• Support corrective and preventive actions related to safety operationsReporting & Insights• Generate and review safety reports, dashboards, and KPI summaries• Interpret safety data and develop analytical insights• Support regulatory submissions and product safety reviews• Provide recommendations based on safety trend analysisRequired QualificationsEducational Requirements• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related fieldExperience and Skills• 5–8 years of experience in pharmacovigilance or drug safety• Hands-on experience with safety databases such as Veeva Vault Safety• Strong knowledge of MedDRA coding standards• Experience with global adverse event reporting requirements• Demonstrated expertise in safety data analytics, signal detection, and dashboard development• Strong analytical and problem-solving abilities• Ability to communicate complex safety insights clearly to stakeholdersSalary InsightsWhile the exact salary package has not been disclosed, senior pharmacovigilance roles in Bangalore with 5–8 years of experience typically offer competitive compensation depending on expertise and company standards.Common benefits may include competitive pay, performance incentives, professional development opportunities, exposure to global safety operations, and career advancement within regulatory affairs and pharmacovigilance.Company OverviewUnilever is one of the world’s leading consumer goods companies, operating in more than 190 countries and serving billions of consumers every day. The organization develops products across categories such as nutrition, personal care, and wellbeing.Through Unilever R&D Bangalore, the company drives research, innovation, and regulatory excellence for global markets. The Global Regulatory Affairs team ensures that products meet strict safety standards while maintaining consumer trust and regulatory compliance. Unilever is also recognized for its commitment to sustainability, diversity, and inclusive workplace practices.FAQsWho can apply for this role?Professionals with 5–8 years of pharmacovigilance experience and a degree in Pharmacy or Life Sciences.Is experience with Veeva Vault Safety required?Yes. Hands-on experience with Veeva Vault Safety or similar pharmacovigilance databases is preferred.What type of work will this role involve?The role focuses on safety data analytics, signal detection, adverse event management, and regulatory reporting.Is this a leadership role?Although it is an individual contributor role, the position involves mentoring junior staff and collaborating with multiple cross-functional teams.Application Tips• Highlight your pharmacovigilance experience and safety analytics expertise• Mention your experience with Veeva Vault Safety or other safety databases• Include knowledge of MedDRA coding and global adverse event reporting standards• Showcase experience in safety dashboards, signal detection, or data analytics projects• Emphasize your ability to analyze complex datasets and communicate insights clearly to stakeholders.

Why This Role MattersMedical reviewers in pharmacovigilance play a crucial role in ensuring drug safety by evaluating adverse event reports and determining their medical significance. Their work helps pharmaceutical companies comply with regulatory standards and ensures that medicines remain safe and effective for patients worldwide.Job DescriptionLatinum HR Solutions is hiring a Medical Reviewer – Pharmacovigilance for a leading Life Sciences organization. This is a non-clinical, full-time role suitable for doctors who want to build a long-term career in drug safety and pharmacovigilance. The role focuses on reviewing Individual Case Safety Reports (ICSRs) in global safety databases and evaluating the medical relevance and causality of reported adverse events.Key Features of the Role• Position: Medical Reviewer – Pharmacovigilance• Company: Latinum HR Solutions• Location: Mumbai, Pune, Bangalore, Chennai, Indore, India• Industry: Life Sciences / Pharmacovigilance / Drug Safety• Employment Type: Full-Time• Work Mode: Work from Office• Experience Required: 3+ YearsResponsibilities• Perform medical review of clinical, spontaneous, solicited, and literature adverse event cases• Assess seriousness, causality, labeling, and medical accuracy of safety cases• Review narratives, adverse event terms, suspect drugs, concomitant medications, lab data, and medical history• Evaluate Individual Case Safety Reports (ICSRs) in global safety databases• Ensure compliance with global and local regulatory guidelines and SOP timelines• Provide medical input and product-related guidance to drug safety teams• Generate, send, and track medical follow-up queries for safety cases• Respond to case-related queries within the safety database• Support audits, internal reviews, and client discussions• Provide medical input for SUSAR and other critical safety casesRequired Qualification• MBBS or equivalent medical degree (Mandatory)Important Requirements• Minimum 3+ years of experience in pharmacovigilance, drug safety, or life sciences domain• Strong medical and clinical knowledge• Understanding of pharmacovigilance and drug safety processes• Computer proficiency including MS Office and safety databases• Excellent written and verbal communication skills• Ability to work effectively in a multidisciplinary team environment• Strong attention to detail and problem-solving abilityWhat We Offer• Opportunity to build a long-term career in pharmacovigilance• Exposure to global drug safety processes• Collaborative work environment within life sciences organizationsExperience and Skills• Pharmacovigilance and drug safety case review• Medical evaluation of adverse events• Clinical knowledge and decision making• Regulatory compliance and SOP adherence• Communication and teamworkCompany OverviewLatinum HR Solutions is a recruitment and talent acquisition firm specializing in hiring professionals for the life sciences, pharmaceutical, biotechnology, and healthcare industries. The company partners with leading organizations to recruit skilled professionals in pharmacovigilance, drug safety, and other specialized healthcare roles.FAQsWhat qualification is required for this role?Candidates must have an MBBS or equivalent medical degree.How much experience is required?A minimum of 3 years of experience in pharmacovigilance or drug safety is required.Is this a clinical or non-clinical role?This is a non-clinical role focused on pharmacovigilance and drug safety review.Where is the job located?The role is available in Mumbai, Pune, Bangalore, Chennai, and Indore.Application Tips• Highlight your MBBS qualification and pharmacovigilance experience• Mention experience in ICSR review and adverse event assessment• Showcase knowledge of drug safety databases and regulatory guidelines• Emphasize analytical skills and medical judgment

Why This Role MattersPharmacovigilance specialists help ensure the safety of medicines by monitoring scientific literature and identifying potential adverse drug reactions. Their work supports regulatory compliance and helps pharmaceutical companies maintain safe and effective medications for patients worldwide.Job DescriptionClarivate is hiring an Associate Pharmacovigilance Specialist for its Life Sciences & Healthcare division in Noida, Uttar Pradesh. This role focuses on reviewing biomedical literature, identifying safety signals, and documenting adverse event information in compliance with pharmacovigilance regulations. It is an excellent opportunity for fresh graduates or early-career professionals interested in drug safety and pharmacovigilance.Key Features of the Role• Position: Associate Pharmacovigilance Specialist• Company: Clarivate• Location: Noida, Uttar Pradesh, India• Industry: Life Sciences & Healthcare / Pharmacovigilance• Employment Type: Full-Time• Work Mode: Hybrid• Experience Required: Fresher – 2 yearsResponsibilities• Review biomedical literature and internal safety alerts to identify potential adverse events• Analyze and summarize biomedical case reports, research studies, and safety-related information• Identify Individual Case Safety Reports (ICSRs) relevant to drug safety monitoring• Prepare brief narratives summarizing safety findings from literature• Assess safety information based on drug labeling and regulatory requirements• Ensure timely and accurate completion of drug safety literature reviews• Track safety assessments and actions using pharmacovigilance systems• Follow standard operating procedures and regulatory compliance guidelinesRequired Qualification• Master’s Degree in Life Sciences, Health Sciences, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.)Important Requirements• 0–2 years of experience in biomedical literature review or pharmacovigilance• Knowledge of biomedical terminology, drugs, and therapeutic areas• Familiarity with biomedical literature databases• Strong analytical and summarization skills• Excellent written and verbal communication in English• Ability to work in a fast-paced environment and adhere to SOPsWork Schedule• Hybrid work mode• Monday to Friday• 9:00 AM – 6:00 PM IST or 11:00 AM – 8:00 PM ISTWhat We Offer• Hybrid working environment• Exposure to global pharmacovigilance projects• Personalized training and professional development opportunities• Opportunity to work with international pharmaceutical clientsExperience and Skills• Biomedical literature analysis• Pharmacovigilance and drug safety monitoring• Medical terminology and therapeutic area knowledge• Data analysis and case report summarization• Time management and attention to detailCompany OverviewClarivate is a global information and analytics company that provides trusted insights and data-driven solutions for life sciences, healthcare, academia, and technology industries. The pharmacovigilance team at Clarivate supports global pharmaceutical companies by monitoring drug safety and ensuring compliance with international regulatory standards.FAQsWhat qualification is required for this role?Candidates must have a Master’s degree in Life Sciences or a related biomedical field.Is experience required for this role?Freshers can apply, but candidates with up to 2 years of relevant experience are preferred.Where is the job located?The role is based in Noida, Uttar Pradesh, India with a hybrid work mode.What are the working hours?The team works Monday to Friday with shifts from 9 AM–6 PM or 11 AM–8 PM IST.Application Tips• Highlight your Master’s degree in Life Sciences or related field• Mention knowledge of biomedical terminology and pharmacovigilance concepts• Showcase experience in literature review or research analysis• Emphasize analytical thinking and communication skills