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Why This Role MattersPharmacovigilance professionals handling ICSR QC and Final Review are critical to ensuring accuracy, compliance, and timely regulatory reporting. Their expertise directly impacts patient safety and global drug safety standards.Job DescriptionAn opportunity is open for experienced Pharmacovigilance professionals with 5–7 years of hands-on experience in case processing and ICSR QC/Final Review. The role is based in Pune and is suitable for immediate joiners only.Key Features of the Role:• Location: Pune• Experience: 5–7 years• Domain: Pharmacovigilance• Specialization: ICSR QC / Final Review• Immediate joiners preferred• Freshers are not eligibleResponsibilities• Perform ICSR Quality Control (QC) and Final Medical Review• Ensure compliance with global pharmacovigilance standards• Validate case accuracy, completeness, and regulatory timelines• Review case narratives and coding• Ensure adherence to client SOPs and regulatory requirements• Collaborate with PV teams for case resolutionRequired Qualifications• Degree in Pharmacy, Life Sciences, or related field• 5–7 years of Pharmacovigilance experience• Strong experience in ICSR QC / Final ReviewExperience and Skills:• In-depth knowledge of PV case processing workflow• Understanding of global regulatory guidelines (FDA, EMA, ICH)• Strong analytical and attention-to-detail skills• Experience in safety databases• Good communication and documentation skillsSalary InsightsSalary not disclosed (market-competitive package expected for experienced PV professionals).FAQsQ1 Are freshers eligible?No, only professionals with 5–7 years of relevant experience should apply.Q2 Is case processing experience mandatory?Yes, hands-on experience in ICSR QC/Final Review is required.Q3 What is the location?Pune.Q4 Are immediate joiners preferred?Yes, immediate joiners are preferred.How to ApplyInterested candidates meeting the criteria can share their CV Application Tips• Clearly highlight ICSR QC / Final Review experience• Mention safety databases worked on (e.g., Argus, ARISg)• Specify total Pharmacovigilance experience• Confirm notice period or immediate availability

Roles & Responsibilities• Signal detection and management within pharmacovigilance processes• Preparation of aggregate safety reports• Collaborating with other teams for safety data analysis and reporting• Providing medical and scientific support for drug safety assessments• Ensuring regulatory compliance and timely submission of safety reportsQualification• MBBS/MD with 1+ years of experience in Pharmacovigilance (PV)Experience• Minimum 1+ years of experience in pharmacovigilanceSkills• Strong expertise in signal detection and safety reporting• Proficient in MedDRA coding and causality assessment• Familiarity with global pharmacovigilance regulations• Excellent communication and teamwork skills• Ability to manage timelines and prioritize tasks effectivelyAbout the CompanyAccenture is a global leader in providing consulting, technology, and outsourcing services. With a strong focus on driving innovation and delivering impactful results, Accenture’s Pharmacovigilance department supports global healthcare initiatives to ensure the safety and efficacy of medicines. We are committed to shaping the future of healthcare through cutting-edge solutions and scientific excellence.

Roles & Responsibilities• Design, develop, and maintain procedures for medical review activities including ICSRs, aggregate reports, and signal management• Perform medical review of ICSRs, PSURs/PBRERs, Risk Management Plans (RMPs), and signal reports• Ensure high quality and regulatory compliance of aggregate and signal management deliverables• Participate in and organize safety label update reviews• Support signal detection and evaluation activities• Mentor and train medical reviewers within the PV team• Provide product and therapeutic area training for pharmacovigilance teams• Conduct cross-functional PV training for medical writing and ICSR team membersQualification• MBBS (MCI Registered or FMGE Qualified)Experience• 0–3 years of Pharmacovigilance experience• Expertise in medical review of aggregate reports (PSURs/PBRERs) – Required• Experience in medical review of signal management and ICSRs – RecommendedSkills• Strong knowledge of global PV regulations and medical review standards• Expertise in aggregate report evaluation and benefit-risk assessment• Understanding of signal management processes• Strong analytical and clinical evaluation skills• Training and mentoring capabilities• Excellent communication and documentation skillsAbout the CompanyThe Accenture is with a reputed pharmaceutical company engaged in global pharmacovigilance operations. The organization focuses on high-quality safety review, regulatory compliance, and continuous professional development within its pharmacovigilance and medical review teams.

Roles & Responsibilities• Identify and create safety cases in global safety databases• Perform triage, case prioritization, and processing of AEs, SAEs, and SUSARs• Conduct medical coding using MedDRA and WHO-Drug Dictionary (WHODD)• Perform data entry and narrative writing in global safety systems• Assess seriousness and causality as per client SOPs• Submit safety reports within defined regulatory timelines• Conduct duplicate checks and validation of case data• Follow up for missing or incomplete safety information• Handle E2B submissions and regulatory reporting requirements• Translate source documents and case narratives where required• Participate in audits and regulatory inspections• Perform mailbox reconciliation and safety data tracking• Ensure strict adherence to global pharmacovigilance regulations and compliance frameworksQualification• B.Pharm (Bachelor of Pharmacy)• BSc Nursing• Bachelor’s Degree in Life SciencesExperience• 0–1 year of experience in Pharmacovigilance or Drug Safety (Freshers can apply)• Basic understanding of global safety reporting requirementsSkills• Knowledge of Pharmacovigilance and Drug Safety processes• Familiarity with safety databases and case processing workflows• Understanding of MedDRA and WHO-Drug coding• Proficiency in MS Office applications• Strong English communication and medical writing skills• High attention to detail and accuracy• Ability to meet strict timelines and quality KPIsAbout the OrganizationAccenture is a global professional services company specializing in digital, technology, and operations solutions. With a strong presence in life sciences and healthcare, Accenture supports global pharmaceutical companies through pharmacovigilance operations, regulatory compliance, and drug safety surveillance services.

Roles & Responsibilities• Perform medical information contact center (MICC) activities and case intake• Process adverse event (AE) and adverse drug reaction (ADR) reports• Ensure timely, accurate, and compliant safety data entry• Follow global pharmacovigilance regulations and internal SOPs• Support safety surveillance and regulatory reporting activities• Maintain proper documentation and quality standardsQualification• B.Pharm / M.Pharm / BDSExperience• Freshers and experienced candidates can applySkills• Basic knowledge of pharmacovigilance or clinical research• Good communication and documentation skills• Understanding of GCP, ICH guidelines, and drug safety concepts• Willingness to learn and adapt in a regulated work environment• Attention to detail and quality-oriented approachAbout the OrganisationPharmazone is a growing organization in the pharmaceutical and clinical research domain, offering opportunities in clinical research and pharmacovigilance. The company provides structured learning, hands-on exposure, and clear career growth paths for freshers and experienced professionals in the life sciences industry.

Roles & Responsibilities• Perform Signal Detection and Signal Management activities for assigned products• Conduct signal validation, prioritization, evaluation, and documentation• Prepare and review Aggregate Safety Reports (PSUR, PBRER, DSUR)• Analyze safety data from multiple sources including clinical trials and post-marketing surveillance• Ensure compliance with global pharmacovigilance regulations and SOPs• Collaborate with cross-functional teams for risk assessment and safety evaluation• For Medics/Physicians: Provide medical review of safety cases and support benefit-risk assessmentQualification• MBBS / MD (for Medics/Physicians)• B.Pharm / M.Pharm / Pharm.D / Life Sciences (for PV professionals)Experience• 4+ years in Signal Detection & Management• Experience in Aggregate Safety Reporting• 1+ year Pharmacovigilance experience (for Medics/Physicians)• Freshers not eligibleSkills• Strong knowledge of global PV regulations (ICH, GVP)• Experience in signal detection tools and safety databases• Expertise in aggregate report writing• Medical review and benefit-risk evaluation skills• Analytical thinking and data interpretation abilities• Strong communication and stakeholder coordination skillsAbout the CompanyAccenture is a globally recognized professional services company offering consulting, technology, and operations services across industries, including life sciences and pharmacovigilance. With a strong focus on innovation, digital transformation, and regulatory excellence, Accenture provides professionals with structured career growth, global exposure, and opportunities to work on large-scale drug safety programs.

Why This Role MattersPatient safety is the foundation of clinical research and pharmaceutical development. Pharmacovigilance ensures that adverse events are properly monitored, assessed, and reported in compliance with global regulatory standards. Effective safety oversight not only protects patients participating in clinical trials but also safeguards public health after products reach the market.The Supervisor – Pharmacovigilance role at ICON plc is central to maintaining high standards of drug safety reporting and regulatory compliance. This position directly influences the accuracy, timeliness, and integrity of adverse event reporting while leading a team responsible for critical safety operations.For professionals with strong pharmacovigilance experience and leadership capabilities, this role offers the opportunity to contribute to global clinical development programs within a world-leading healthcare intelligence and clinical research organization.Job DescriptionICON plc is seeking a Supervisor – Pharmacovigilance to join its dynamic and diverse team. The selected candidate will oversee day-to-day pharmacovigilance operations related to clinical trials and marketed products. The role involves supervising safety reporting processes, ensuring regulatory compliance, managing submission workflows, and guiding the pharmacovigilance team to maintain best-in-class reporting standards.The Supervisor will collaborate with cross-functional departments including clinical operations, regulatory affairs, and quality teams to optimize safety reporting systems and maintain compliance with global pharmacovigilance regulations. This position requires strong technical knowledge, leadership skills, and the ability to manage multiple safety workflows simultaneously.Key Features of the RoleLeadership opportunity within global pharmacovigilance operations.Exposure to clinical trial and post-marketing safety reporting.Direct interaction with regulatory authorities and global compliance frameworks.Collaboration with cross-functional global teams.Career progression within a leading clinical research organization.Responsibilities RequiredSupervise day-to-day pharmacovigilance safety reporting operations, ensuring timely and accurate submission of adverse event reports to regulatory authorities.Oversee safety case processing, medical review coordination, and submission tracking in accordance with global regulatory timelines.Ensure compliance with international pharmacovigilance regulations, guidelines, and internal standard operating procedures (SOPs).Manage safety submissions workflow and ensure proper documentation, quality checks, and audit readiness.Collaborate with clinical operations, regulatory affairs, and quality assurance teams to streamline safety reporting processes.Provide leadership, mentoring, and training to pharmacovigilance team members to ensure adherence to best practices.Monitor performance metrics and implement process improvements to enhance reporting efficiency and compliance.Support regulatory inspections and audits by preparing required documentation and addressing safety-related queries.Ensure accurate maintenance of safety databases and tracking systems.Identify potential compliance risks and implement corrective and preventive actions (CAPA) where required.Maintain high standards of data accuracy, confidentiality, and regulatory integrity across all pharmacovigilance activities.QualificationsThe ideal candidate will possess a strong academic background in life sciences or pharmacy, combined with practical pharmacovigilance and leadership experience.Educational Requirements:Bachelor’s degree in Life Sciences, Pharmacy, or a related field.Experience and Skills:Solid experience in pharmacovigilance or drug safety, particularly in clinical trials and/or post-marketing surveillance.Strong knowledge of global pharmacovigilance regulations and reporting guidelines (e.g., ICH, FDA, EMA frameworks).Experience supervising or mentoring pharmacovigilance team members.Strong understanding of safety database systems and submission workflows.Excellent communication and organizational skills.Ability to manage multiple priorities and ensure compliance with strict regulatory timelines.High attention to detail and commitment to data accuracy.Ability to work effectively in a cross-functional and global team environment.Salary InsightsCompensation will be competitive and aligned with global CRO industry standards for supervisory-level pharmacovigilance professionals. The overall package may include performance-based incentives and country-specific benefits aligned with experience and role responsibility.Additional benefits may include:Competitive salary structureHealth insurance options for employees and familiesRetirement planning benefitsLife assurance coverageGlobal Employee Assistance Programme (LifeWorks)Flexible, country-specific optional benefits such as childcare vouchers, gym memberships, and travel subsidiesGenerous annual leave entitlementsCompany OverviewICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to advancing clinical development and improving patient outcomes. The company operates globally, supporting pharmaceutical, biotechnology, and medical device clients in delivering high-quality clinical research solutions.ICON fosters a culture of inclusion, innovation, and excellence, providing professionals with opportunities to grow within a diverse and performance-driven environment. The organization is committed to maintaining a workplace free from discrimination and promoting equal opportunity for all employees.FAQsIs supervisory experience mandatory for this role?Yes, prior experience in leading or mentoring pharmacovigilance teams is highly preferred.Does this role focus only on clinical trials?The role covers both clinical trial safety reporting and post-marketing surveillance activities.What regulatory knowledge is required?Strong knowledge of global pharmacovigilance regulations such as ICH guidelines and regulatory authority requirements (e.g., FDA, EMA).Are cross-functional collaborations involved?Yes, the role requires close coordination with clinical operations, regulatory affairs, and quality teams.What is the primary objective of the role?To ensure accurate, timely, and compliant safety reporting while leading pharmacovigilance operations effectively.Application TipsHighlight your pharmacovigilance experience, especially supervisory or leadership responsibilities.Mention regulatory frameworks and safety databases you have worked with.Provide examples of managing submission timelines and regulatory compliance.Demonstrate experience handling audits or inspections related to safety reporting.Be prepared to discuss real-world pharmacovigilance workflow management scenarios during the interview.

Why This Role MattersThe Pharmacovigilance Intern role at CliniResource provides an essential entry point into the highly regulated and critical field of drug safety and pharmacovigilance. Pharmacovigilance plays a vital role in protecting patient safety by monitoring, assessing, and reporting adverse drug reactions in compliance with global regulatory frameworks.This internship offers fresh graduates structured exposure to real-world pharmacovigilance workflows followed by pharmaceutical companies and Contract Research Organizations (CROs). By contributing to adverse event case processing, safety documentation, and regulatory compliance activities, interns gain foundational experience that directly supports public health and regulatory transparency.For candidates seeking pharmacovigilance internship jobs in Delhi/NCR, this opportunity strengthens industry readiness and builds the professional discipline required in global drug safety operations.Job DescriptionCliniResource is offering an office-based Pharmacovigilance Internship for fresh M.Pharm, Pharm.D, and BDS graduates located in New Delhi/NCR. This role is designed to provide structured, hands-on training in pharmacovigilance case processing, adverse event reporting, and regulatory documentation practices.The selected interns will work closely with safety and regulatory teams to process Adverse Event (AE) and Serious Adverse Event (SAE) reports, assist in Individual Case Safety Report (ICSR) documentation, maintain safety databases, and support compliance activities aligned with ICH and global pharmacovigilance guidelines.This internship focuses on building core competencies required for entry-level drug safety and pharmacovigilance roles within pharmaceutical companies and CRO environments.Key Features of the Role• Structured hands-on training in pharmacovigilance operations• Exposure to AE and SAE case processing workflows• Practical learning of ICSR documentation procedures• Compliance alignment with ICH and global regulatory standards• Real-time safety database management experience• Office-based professional learning environment• Direct interaction with pharmacovigilance and regulatory professionals• Foundational training for long-term drug safety careersResponsibilities Required• Process and review Adverse Event (AE) reports• Assist in handling Serious Adverse Event (SAE) documentation• Support preparation and review of Individual Case Safety Reports (ICSRs)• Maintain accurate safety database entries and documentation records• Assist in aggregate safety data review activities• Ensure compliance with ICH guidelines and global pharmacovigilance standards• Coordinate with internal safety and regulatory teams for case follow-up• Support documentation accuracy and case tracking processes• Maintain confidentiality and data integrity across safety workflows• Participate in internal training and quality review sessionsQualifications• M.Pharm (Pharmacology or Pharmaceutics preferred)• Pharm.D• BDSEducational Requirements• Completed postgraduate or professional degree in Pharmacy or Dentistry• Academic understanding of pharmacology, drug safety, and adverse event monitoringExperience and Skills• Fresh graduates are eligible• Strong conceptual understanding of pharmacovigilance principles• Basic knowledge of ICH guidelines and global drug safety regulations• Good written and verbal communication skills• Strong attention to detail and documentation accuracy• Ability to understand and interpret medical terminology• Structured and process-oriented working style• Basic computer proficiency for database documentation• Willingness to learn regulated safety workflows• Ability to work effectively in an office-based professional settingSalary Insights• Estimated stipend: ₹12,000 – ₹18,000 per month• Compensation aligned with industry standards for pharmacovigilance interns in Delhi/NCR• Internship provides high-value industry exposure beyond monetary compensation• Strong return on investment in terms of long-term career growth potentialCompany OverviewCliniResource operates within the pharmaceutical and clinical research domain, supporting pharmacovigilance and drug safety operations. The organization focuses on providing structured training and operational exposure to fresh graduates entering regulated healthcare environments.Through practical safety case processing, compliance documentation, and regulatory alignment, CliniResource enables early-career professionals to develop strong foundations in pharmacovigilance operations. The company emphasizes process discipline, regulatory accuracy, and professional development within a structured office-based environment.FAQs• Q: Is this internship remote?A: No. This is an office-based internship located in New Delhi/NCR.• Q: Are freshers eligible?A: Yes. Fresh M.Pharm, Pharm.D, and BDS graduates are encouraged to apply.• Q: Is prior pharmacovigilance experience required?A: No prior industry experience is mandatory, but basic conceptual understanding is expected.• Q: Will interns receive hands-on ICSR exposure?A: Yes. Interns will assist in ICSR documentation and safety case processing workflows.• Q: What career roles can this internship lead to?A: This internship builds a foundation for roles such as Drug Safety Associate, Pharmacovigilance Executive, Safety Scientist, or Clinical Research professional.• Q: Are candidates outside Delhi/NCR eligible?A: No. Only candidates residing in Delhi/NCR are eligible.Application Tips• Highlight academic projects related to pharmacovigilance or drug safety• Mention coursework in pharmacology, clinical research, or regulatory affairs• Demonstrate understanding of AE, SAE, and ICSR concepts• Emphasize documentation accuracy and attention to detail• Showcase strong communication skills in your resume• Prepare to discuss basic ICH guidelines during interviews• Express willingness to learn structured, regulated workflows

Why This Role MattersPharmacovigilance professionals play a critical role in safeguarding public health by monitoring, evaluating, and reporting drug safety data. Aggregate safety reports such as PADERs, PSURs, PBRERs, and Risk Management Plans (RMPs) are essential regulatory documents that ensure ongoing benefit-risk evaluation of medicinal products.As an Officer – Pharmacovigilance at Unichem Laboratories, you will contribute directly to global drug safety compliance, regulatory reporting accuracy, and adherence to international standards such as FDA, ICH-GCP, and GVP guidelines. This role is ideal for pharmacy professionals aiming to build a strong career in drug safety and regulatory science.Job DescriptionUnichem Laboratories is hiring for the position of Officer – Pharmacovigilance (Aggregate Report Drafting) in Mumbai. This is a full-time, permanent opportunity for professionals with 1–6 years of pharmacovigilance experience, particularly in aggregate safety reporting.The selected candidate will be responsible for drafting, reviewing, and maintaining periodic safety reports and ensuring compliance with global regulatory requirements. The role also involves supporting pharmacovigilance operations, conducting training sessions, and collaborating with Medical Affairs and other internal stakeholders.Key Responsibilities• Support execution of pharmacovigilance (PV) activities• Prepare and maintain PV documents, SOPs, and Work Instructions (WIs)• Draft and review aggregate safety reports, including:• Periodic Adverse Drug Experience Reports (PADERs)• Periodic Safety Update Reports (PSURs)• Periodic Benefit-Risk Evaluation Reports (PBRERs)• Risk Management Plans (RMPs)• Ensure compliance with company SOPs and global regulatory requirements• Monitor regulatory authority websites for safety updates and compliance changes• Provide accurate responses to medical information queries• Conduct PV training sessions for internal teams, manufacturing plants, and vendors• Support Medical Affairs in pharmacovigilance-related inquiriesThis position provides comprehensive exposure to global drug safety regulations and aggregate report drafting processes.Eligibility CriteriaEducational Qualification:• B.Pharm (Bachelor of Pharmacy)• M.Pharm (Any Specialization Preferred)Experience:• 1–6 years of pharmacovigilance experience• Hands-on experience in aggregate safety report drafting preferredDesired Skills & Competencies• Strong understanding of international regulatory requirements including FDA, ICH-GCP, and GVP Modules• Knowledge of EU Clinical Trial Directive• Experience in pharmacovigilance aggregate report drafting• Excellent written and verbal communication skills• Strong analytical and decision-making abilities• High attention to detail in drug safety documentation• Ability to work effectively in dynamic, cross-functional teamsSalary & BenefitsCompensation: Competitive salary aligned with industry standards, based on experience and expertise.Additional Benefits:• Opportunity to work with a reputed pharmaceutical organization• Exposure to global regulatory frameworks (FDA, ICH, GVP)• Strong career progression in pharmacovigilance and drug safety• Corporate exposure in a Mumbai-based pharmaceutical setup• Professional development in regulatory documentation and complianceCompany OverviewUnichem Laboratories is a well-established pharmaceutical company engaged in the development, manufacturing, and marketing of pharmaceutical formulations and active pharmaceutical ingredients.The organization emphasizes regulatory compliance, quality standards, and global pharmacovigilance practices. Working at Unichem offers professionals exposure to structured drug safety systems and international reporting standards.FAQsQ: Is aggregate report drafting experience mandatory?Experience in drafting PADERs, PSURs, PBRERs, or RMPs is highly preferred for this role.Q: What level of experience is required?Candidates with 1–6 years of pharmacovigilance experience are eligible to apply.Q: Is this role focused only on documentation?The primary focus is aggregate report drafting, but it also includes PV compliance monitoring, training, and coordination with Medical Affairs.Q: Where is the job location?The position is based in Mumbai.Application Tips• Highlight specific aggregate reports you have drafted or reviewed• Mention exposure to FDA, ICH-GCP, and GVP guidelines• Showcase analytical skills and experience in benefit-risk evaluation• Demonstrate familiarity with SOP-based environments• Prepare to discuss regulatory inspection or audit exposure

Why This Role MattersPharmacovigilance Coordinators are central to ensuring patient safety through efficient case management, regulatory compliance, and real-time workflow monitoring. In global drug safety operations, timely adverse event reporting and adherence to GVP and FDA regulations directly influence regulatory trust, product continuity, and public health protection.Job DescriptionProductLife Group is hiring a Pharmacovigilance Coordinator (Remote – India, Full-Time). The role focuses on pharmacovigilance workflow case management, adverse event reporting oversight, safety compliance monitoring, and coordination of global drug safety operations. This opportunity is ideal for professionals with 3–4+ years of hands-on PV experience seeking international exposure.Key Features of the Role:• Remote position (India-based)• Full-time employment• 3–4+ years experience required• Exposure to global safety standards• Focus on workflow optimization and compliance• International regulatory environmentResponsibilities• Monitor real-time pharmacovigilance workflow performance• Optimize task distribution and resource allocation• Track case processing timelines and ensure compliance with deadlines• Ensure proper assignment of safety cases• Collaborate with operational and development teams• Provide technical support and cross-training• Investigate workflow issues and implement corrective solutions• Analyze performance metrics for workflow improvement• Coordinate safety-related projects• Maintain structured documentation in compliance with global standardsRequired Qualifications• Degree in Life Sciences or higher• Experience in pharmacovigilance workflow case management• Hands-on exposure to adverse event reporting and causality assessment• Knowledge of GVP guidelines and FDA regulations• Understanding of cosmetic safety regulations• Experience in SDEA/PVA interpretationEducational Requirements:• B.Pharm, M.Pharm, Pharm.D• MSc, BSc (Life Sciences) or higher qualificationExperience and Skills:• 3–4+ years in Pharmacovigilance operations• Strong understanding of global regulatory safety requirements• Proficiency in Microsoft Office Suite• Database management experience• Analytical and problem-solving skills• Project coordination and documentation expertise• Strong communication and teamwork abilities• High adaptability and accountabilityAge Eligibility:As per company normsSalary InsightsSalary not disclosed. Competitive compensation aligned with industry standards and experience level.Company OverviewProductLife Group is a global life sciences consulting organization supporting pharmaceutical, biotech, and medical device companies in regulatory, pharmacovigilance, and quality compliance services. The company provides international exposure and opportunities to work on cross-border regulatory projects within a collaborative professional environment.FAQsIs this role fully remote?Yes, this is a remote role based in India.Is prior pharmacovigilance experience mandatory?Yes, 3–4+ years of relevant pharmacovigilance workflow experience is required.Is knowledge of GVP and FDA regulations necessary?Yes, strong knowledge of GVP guidelines and FDA regulations is essential.Does the role involve project coordination?Yes, coordination and documentation of safety projects are part of the responsibilities.How can candidates apply?Interested candidates can apply via the provided link or send resumesApplication Tips• Highlight hands-on ICSR and workflow management experience• Mention experience with GVP, FDA, and SDEA/PVA interpretation• Emphasize regulatory compliance exposure• Showcase data tracking and performance analysis skills• Keep resume focused on global pharmacovigilance experience

Why This Role MattersPharmacovigilance within a specialty pharmacy setting is essential to safeguarding patients who rely on high-risk, complex, or chronic therapies. Continuous monitoring of adverse events, drug interactions, and safety signals ensures compliance with regulatory requirements and strengthens patient trust.This role plays a critical function in maintaining drug safety standards, enhancing reporting accuracy, and supporting quality improvement initiatives. By collaborating with clinical and compliance teams, the position contributes directly to patient well-being and regulatory excellence.Job DescriptionThe Pharmacovigilance Associate is responsible for overseeing drug safety monitoring, adverse event reporting, regulatory compliance, and quality assurance activities. The role involves collection and evaluation of safety data, preparation of regulatory submissions, and implementation of pharmacovigilance policies aligned with industry standards.The position requires strong analytical skills, attention to detail, and the ability to work both independently and collaboratively in a fast-paced specialty pharmacy environment.Key Features of the Role• Direct involvement in adverse event monitoring and reporting• Exposure to regulatory compliance and safety management processes• Collaboration with clinical and compliance teams• Participation in risk management and quality assurance activities• Opportunity to contribute to SOP development and staff training• Competitive compensation and career growth opportunitiesResponsibilities• Monitor, evaluate, and report adverse events and potential drug interactions as per regulatory requirements• Collect, assess, and document pharmacovigilance data from patients, healthcare providers, and stakeholders• Perform root cause analyses to identify safety issues and implement corrective actions• Prepare and submit pharmacovigilance reports within regulatory timelines• Collaborate with clinical and compliance teams for follow-up reporting and documentation• Develop, update, and implement pharmacovigilance policies, SOPs, and protocols• Conduct risk assessments and contribute to risk management planning• Provide pharmacovigilance training and awareness sessions for staff• Stay updated with regulatory changes and adapt safety processes accordingly• Reconcile monthly safety reports to verify data accuracy and identify discrepancies• Conduct audits and quality reviews of pharmacovigilance processes• Perform additional drug safety responsibilities as assignedRequired Qualifications• Strong understanding of pharmacovigilance regulations and safety reporting requirements• Knowledge of pharmacological and medical terminology• Proficiency in safety databases and reporting tools• Strong analytical and organizational skills• Excellent written and verbal communication abilities• Commitment to patient safety and regulatory complianceEducational Requirements• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related healthcare field preferredExperience and Skills• Minimum 2 years of experience in pharmacovigilance or drug safety (mandatory)• Experience in specialty pharmacy or clinical setting preferred• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat• Experience handling safety databases and information management systems• Ability to work independently and within cross-functional teams• Strong attention to detail and documentation accuracySalary Insights• Monthly salary range: ₹30,000 – ₹60,000• Compensation depends on experience, regulatory exposure, and database expertise• Candidates with strong safety reporting and audit experience may be positioned at the higher end of the salary rangeCompany OverviewRx Connect Specialty Pharmacy is a leading specialty pharmacy dedicated to providing high-quality medications and patient support services for individuals with complex, chronic, and rare conditions. The organization focuses on patient safety, regulatory compliance, and excellence in pharmacy operations. With a commitment to continuous quality improvement, Rx Connect Specialty Pharmacy aims to enhance therapeutic outcomes while maintaining the highest safety standards.FAQs• Is pharmacovigilance experience mandatory? Yes, a minimum of 2 years of relevant experience is required.• Is this an on-site role? Yes, the work location is in-person in Mohali, Punjab.• Does the role involve regulatory reporting? Yes, preparation and submission of safety reports is a key responsibility.• Are there growth opportunities? Yes, the company offers career advancement within its expanding operations.Application Tips• Highlight specific adverse event reporting experience• Mention safety database expertise clearly• Demonstrate experience in SOP development or audit participation• Emphasize collaboration with clinical or compliance teams• Showcase measurable contributions to patient safety or quality improvements

Why This Role MattersPharmacovigilance plays a critical role in protecting patient safety by monitoring, detecting, and preventing adverse drug reactions. As a Pharmacovigilance Associate at Tata Consultancy Services, you will contribute directly to global drug safety operations, ensuring regulatory compliance and supporting pharmaceutical clients in maintaining high-quality safety standards. This role is essential in strengthening patient trust, maintaining regulatory integrity, and supporting life sciences innovation through structured safety monitoring and reporting.Job DescriptionTata Consultancy Services is hiring Pharmacovigilance Associates to support adverse event case processing, safety data management, and regulatory compliance activities. The selected candidate will be responsible for reviewing and processing Individual Case Safety Reports (ICSRs), performing drug safety data entry and validation, and ensuring accurate and timely submission of regulatory reports. The role requires hands-on experience with safety databases such as Argus or ARISg and strong knowledge of global pharmacovigilance regulations.Key Features of the Role:• Exposure to global pharmacovigilance operations• Opportunity to work with leading pharmaceutical clients• Hands-on experience with Argus Safety and ARISg databases• Involvement in signal detection and risk assessment support• Cross-functional collaboration within life sciences teams• Competitive salary structure aligned with industry standardsResponsibilities• Process and review adverse event case reports• Perform drug safety data entry and validation• Ensure compliance with global pharmacovigilance regulations• Work on safety databases such as Argus or ARISg• Conduct case follow-ups and resolve safety queries• Prepare and review case narratives• Maintain accuracy and completeness of safety data• Collaborate with cross-functional teams for safety reporting• Support signal detection and risk assessment activities• Participate in audits and regulatory inspections• Maintain documentation as per SOPs and guidelines• Ensure timely submission of regulatory reports• Identify discrepancies and resolve safety data issues• Assist in quality control and compliance checksRequired Qualifications• University Graduate (Life Sciences, Pharmacy, Biotechnology, Nursing, or related field preferred)• 2–4 years of experience in pharmacovigilance or drug safety• Experience in ICSR processing and case management• Hands-on knowledge of Argus Safety or ARISgEducational Requirements:• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline• Relevant certification in Pharmacovigilance preferredExperience and Skills:• Strong understanding of pharmacovigilance and drug safety processes• Expertise in ICSR case processing• Knowledge of global regulatory compliance requirements• Proficiency in Argus Safety or ARISg• Good understanding of medical terminology• Strong analytical and data review skills• Attention to detail and quality-focused mindset• Effective communication and documentation skills• Ability to work within defined timelines and SOP frameworksAge Eligibility:No specific age criteria mentioned. Candidates must meet educational and experience requirements.Salary Insights₹4,00,000 – ₹8,00,000 per annum (based on experience and expertise). Compensation may vary depending on candidate profile, project allocation, and skill level.Company OverviewTata Consultancy Services (TCS) is a global IT services, consulting, and business solutions organization delivering technology-driven solutions to leading enterprises worldwide. With a strong presence in life sciences and healthcare domains, TCS supports pharmaceutical and biotech organizations in pharmacovigilance, regulatory operations, clinical research, and digital transformation initiatives. TCS operates across multiple countries and is known for innovation, operational excellence, and client-centric solutions.FAQs1. Is experience in Argus mandatory?Experience in Argus or ARISg is strongly preferred.2. Is this a client-facing role?The role involves collaboration with internal and external stakeholders in safety reporting.3. Is remote work available?Location is specified as Mumbai / Pune; work model depends on project allocation.4. What growth opportunities are available?Career progression may include Senior PV Associate, Drug Safety Specialist, or Quality Reviewer roles.Application Tips• Highlight ICSR processing and case narrative experience clearly• Mention safety database expertise (Argus/ARISg) prominently• Showcase knowledge of global PV regulations• Quantify case volume handled per month if possible• Emphasize audit experience and compliance adherence• Tailor your CV specifically for pharmacovigilance keywords

Why This Role MattersThis Clinical Safety / Pharmacovigilance position offers a unique opportunity to contribute to patient safety and the lifecycle management of pharmaceutical products. You will play a critical role in monitoring, evaluating, and reporting adverse events (AEs) from clinical trials and post-marketing activities. By ensuring accurate and timely safety reporting, you directly support regulatory compliance, safeguard patient health, and help maintain the integrity of clinical studies and marketed products. This role is ideal for individuals looking to grow in the pharmacovigilance or clinical safety field, gain hands-on regulatory experience, and contribute to a global healthcare impact.Job DescriptionFortrea is seeking a detail-oriented Clinical Safety Specialist to join our growing team. The successful candidate will manage and process expedited adverse events (AEs/SAEs), maintain safety databases, support regulatory submissions, and provide high-quality service to clients and internal teams. You will work closely with Clinical Operations, Data Management, and Regulatory teams to ensure compliance with national and international standards, including ICH-GCP, Good Clinical Practice, and global pharmacovigilance requirements.This role requires a proactive individual capable of handling multiple safety cases while maintaining strict accuracy and regulatory compliance. You will assist with signal detection, safety reporting, quality review, and documentation management, contributing to the overall success of clinical trials and post-marketing safety programs.Key Features of the Role• Exposure to global pharmacovigilance and clinical safety operations• Hands-on experience with AE/SAE reporting, safety database management, and regulatory submissions• Work across multiple therapeutic areas and client projects• Opportunity to participate in signal detection and safety trend analysis• Mentorship and career growth within an international CRO environment• Involvement in audits, inspections, and CAPA implementation• Collaborative cross-functional team environment• Opportunity to support both clinical trial and post-marketing safety projectsResponsibilities• Manage receipt and processing of all adverse event reports, whether spontaneous or from clinical trials• Enter safety data into AE databases and tracking systems accurately• Review adverse events for completeness, accuracy, and expedited reporting readiness• Write patient narratives and code events using MedDRA• Determine listedness against product labels for marketed products• Identify clinically significant missing information and ensure follow-up• Submit expedited AE/SAE reports to clients, regulatory authorities, ethics committees, and investigators within study-specified timelines• Perform database reconciliation with Data Management or sponsors as required• Maintain adverse event tracking systems and ensure all project files are up to date• Assist with the reporting of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)• Participate in signal detection, trend analysis, and pattern recognition activities• Support preparation of Annual IND reports, PSURs, and DSURs• Prepare and maintain study safety files for archiving at project completion• Support audits, inspections, and quality assurance initiatives• Assist with CAPA development and implementation for safety-related findings• Mentor and train junior safety staff in AE processing and pharmacovigilance procedures• Maintain up-to-date knowledge of Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelinesRequired Qualifications• PharmD, MS/MA, BS/BA, or Associate degree in Pharmacy, Biological Sciences, Nursing, Life Sciences, or related field• Relevant experience in safety/pharmacovigilance or CRO/biotech/pharmaceutical industry• Experience with AE/SAE processing, safety databases, narratives, queries, and regulatory submissions• Knowledge of ICH Guidelines and worldwide regulatory requirements• Ability to work independently with minimal supervision• Excellent written and verbal communication skillsEducational Requirements• BS/BA, PharmD, or equivalent degree in a health sciences, medical, pharmacy, or life sciences discipline• Non-degree candidates with 2+ years of clinical safety experience may be considered• Postgraduate education or relevant certifications in pharmacovigilance or clinical research preferredExperience and Skills• Minimum 1–2 years of experience in pharmacovigilance, clinical safety, or related area• High attention to detail and accuracy in handling sensitive clinical data• Strong organisational skills with the ability to manage multiple tasks simultaneously• Proficient in Microsoft Office (Word, Excel, Outlook) and database systems• Team player with the ability to liaise with clients, investigators, and regulatory personnel• Understanding of GCP, pharmacovigilance processes, and regulatory safety requirements• Ability to review cumulative safety data for submissions to regulatory authorities or DSMBsSalary Insights• Competitive industry-aligned remuneration based on experience and qualifications• Opportunities for bonuses or career progression within the pharmacovigilance team• Additional benefits include professional training, mentorship, and potential travel opportunities (~5%)Company OverviewFortrea is a global Contract Research Organisation (CRO) committed to delivering high-quality clinical research and pharmacovigilance services. We support pharmaceutical, biotech, and medical device companies by providing end-to-end clinical trial solutions and safety monitoring services. Our team collaborates with clients, regulatory authorities, and clinical research teams worldwide, ensuring the highest standards of patient safety and compliance.Our culture is collaborative, professional, and supportive, with opportunities for career growth, continuous learning, and exposure to international regulatory and safety practices.FAQsQ: What type of safety experience is required?A: Experience with AE/SAE processing, writing narratives, database entry, regulatory submissions, and pharmacovigilance procedures is required.Q: Is travel required?A: Minimal travel (~5%) may be required for audits or project-related visits, including overnight stays.Q: Do I need prior clinical trial experience?A: Prior clinical trial experience is highly desirable but not mandatory if you have relevant pharmacovigilance or safety experience.Q: What training is provided?A: Fortrea provides comprehensive training in safety databases, regulatory processes, AE/SAE reporting, and SOP compliance.Q: Can non-degree holders apply?A: Yes, candidates with extensive safety experience (2+ years) will be considered.Application Tips• Ensure your CV highlights relevant safety, pharmacovigilance, or clinical trial experience• Include examples of AE/SAE processing, regulatory submissions, or quality/compliance work• Mention any experience with safety databases, MedDRA coding, or PSUR/DSUR reporting• Highlight your ability to work independently and manage competing priorities• Include any relevant certifications, training, or postgraduate qualifications in clinical safety• Demonstrate communication, attention to detail, and teamwork skills

Why This Role MattersPharmacovigilance is central to patient safety, regulatory compliance, and maintaining the benefit-risk profile of medicinal products throughout their lifecycle. In markets such as Japan, strict regulatory oversight by the Pharmaceuticals and Medical Devices Agency requires precise, timely, and compliant safety reporting.This role ensures high-quality case processing, regulatory submissions, literature surveillance, and compliance monitoring aligned with global and Japanese pharmacovigilance requirements. By supporting expedited reporting, ICSR compliance, and regulatory database management, the position plays a direct role in inspection readiness and maintaining trust with Health Authorities and business partners.Job DescriptionThe Japanese Pharmacovigilance Specialist is responsible for executing drug safety activities including case processing, regulatory reporting, literature search and review, compliance tracking, and coordination with Japanese-speaking stakeholders.The role requires strong knowledge of global and Japanese pharmacovigilance regulations, hands-on safety database experience, and the ability to communicate effectively in both English and Japanese.Key Features of the Role• End-to-end involvement in ICSR case processing and compliance activities• Exposure to Japanese regulatory requirements and PMDA pharmacovigilance activities• Interaction with global and Japanese-speaking PV teams• Participation in audits, inspections, and compliance metric tracking• Involvement in regulatory database lifecycle management• Contribution to literature surveillance and signal support activitiesResponsibilitiesGeneral Pharmacovigilance Activities• Maintain working knowledge of adverse event safety profiles, labeling documents, client guidelines, SOPs, and global safety regulations• Ensure compliance with internal and regulatory timelines for adverse event reporting• Assist in development of project-specific safety workflows and templates• Participate in audits and inspections and support follow-up activities• Monitor performance metrics and ensure compliance with client-defined standards• Liaise with client stakeholders to ensure delivery of high-quality work• Mentor new team members when required• Archive source documents and relevant communication appropriatelyCase Processing• Monitor incoming safety reports from mailboxes, EudraVigilance, literature searches, and other sources• Perform triage for completeness, validity, and medical consistency• Create and process cases in the safety database• Perform accurate data entry in accordance with SOPs and client guidelines• Ensure correctness of expectedness, seriousness, and causality assessments• Perform MedDRA coding as per “MedDRA Term Selection: Points to Consider”• Conduct follow-up activities and query management• Draft medically cohesive case narratives• Perform quality and validation checks before workflow progression• Support reconciliation activities with Data Management teams• Generate line listings and tabulations for periodic and ad hoc safety reports• Investigate late ICSRs and document corrective actions• Generate and reconcile compliance metricsDrug Safety Reporting• Perform quality control of case reports and safety submissions• Maintain local and global reporting requirements• Register and manage electronic reporting with relevant authorities• Coordinate submissions to regulatory authorities, ethics committees, and investigators• Track submission status and maintain documentation• Perform unblinding of SUSARs where applicable• Collaborate with global PV teams for requirement collectionRegulatory Affairs Support• Maintain and update regulatory databases with product lifecycle changes• Create applications, regulatory events, variations, and references in regulatory systems• Support EU region procedures including National, Centralized, Mutual Recognition, and Decentralized processes• Validate SmPC data and perform xEVMPD submissions via EMA Gateway• Generate marketing authorization status reportsLiterature Search and Review• Develop and maintain search strategies based on client-defined parameters• Retrieve, review, and process literature citations• Identify valid cases and enter into safety database• Maintain local journal listings• Perform quality checks on search strategies• Monitor database thesauri updates and implement necessary revisionsRequired Qualifications• Strong knowledge of drug safety and drug development processes• Ability to interpret and apply global safety regulations• Understanding of regulatory submission processes• Proficiency in safety databases and literature search tools• Strong analytical and problem-solving abilities• Client-focused and quality-driven approachEducational Requirements• Degree in Life Sciences, Health Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, or related discipline• Degree in Medicine, Dentistry, Physiotherapy, Nursing, or similar healthcare field is advantageousExperience and Skills• Experience in pharmacovigilance or drug safety activities preferred• Good knowledge of medical terminology• Experience with PMDA pharmacovigilance requirements• Experience working with Japanese-speaking PV case processing teams• Proficiency in English (written and spoken)• Japanese language proficiency – JLPT N2 or above (mandatory)• Strong communication and interpersonal skills• Excellent organizational and prioritization abilities• Ability to manage multiple tasks independently• Strong IT proficiency including MS Office and web-based systemsSalary Insights• Compensation varies based on PV experience, Japanese language proficiency level, and regulatory exposure• Candidates with PMDA reporting experience and JLPT N2 or higher certification typically fall within mid-to-senior compensation brackets• Bilingual PV professionals often command competitive salary premiums due to specialized market demandCompany OverviewOrganizations operating in global pharmacovigilance environments collaborate with international regulatory bodies including the Pharmaceuticals and Medical Devices Agency and the European Medicines Agency to ensure compliance with safety reporting standards.This role supports adherence to global and Japanese safety regulations while maintaining high standards of quality and inspection readiness.FAQs• Is Japanese language proficiency mandatory? Yes, JLPT N2 or higher certification is required.• Is PMDA experience necessary? It is strongly preferred, particularly for Japan-focused pharmacovigilance activities.• Does the role involve case processing? Yes, hands-on case processing and compliance monitoring are core responsibilities.• Will the role involve regulatory submissions? Yes, electronic reporting and lifecycle regulatory updates are included.Application Tips• Highlight PMDA reporting experience and Japanese PV exposure• Mention JLPT certification level clearly on your resume• Emphasize hands-on safety database experience• Showcase examples of compliance metric tracking or late case investigation• Demonstrate ability to manage bilingual communication in safety operations

Roles & Responsibilities• Collect, review, and process Adverse Event (AE) and Serious Adverse Event (SAE) reports• Perform case processing and data entry in safety databases such as Argus, ARISg, Oracle, or similar systems• Conduct literature searches and review scientific publications for safety-related information• Assist in signal detection, risk assessment, and safety trend analysis• Ensure compliance with ICH-GCP, ICH-E2B, and applicable regulatory guidelines• Support preparation and review of PSURs, PBRERs, and other regulatory safety documents• Maintain accurate, complete, and audit-ready pharmacovigilance documentation• Coordinate with Clinical, Regulatory, Quality, and other cross-functional teams• Follow SOPs, timelines, and quality standards for safety reportingQualification• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related disciplineExperience• Freshers are eligible to apply• Internship or academic exposure to pharmacovigilance or clinical research is an advantageSkills• Basic understanding of pharmacovigilance concepts and safety reporting• Knowledge of ICH-GCP and global drug safety regulations• Strong attention to detail and documentation skills• Good written and verbal communication skills• Ability to work in a team-oriented and compliance-driven environment• Willingness to learn safety databases and PV workflowsAbout the OrganisationThe organization is a growing healthcare and life sciences company focused on ensuring patient safety and regulatory compliance through high-quality pharmacovigilance and drug safety services, offering strong learning and career development opportunities for fresh graduates.

Role & Responsibilities • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. • Review includes coding, assessment of seriousness, expectedness, and causality. • Write Company comments, follow-up questions, and analyze similar events. • Complete all required supporting documentation, such as trackers. • Support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues. • Review and provide input in periodic reports. • Review literature screening search strategies and review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings. Qualification • MD qualification is required. Experience • Proven ability to plan, organize, prioritize, and execute multiple tasks efficiently. Skills • Ability to work cross-culturally and cross-functionally, valuing teamwork. • Strong communication and presentation skills. • Advanced English skills, both verbal and written (at least B2 level). • Advanced knowledge of MS Office. About The Company • PrimeVigilance offers an opportunity for Medical Doctors to develop a career in Drug Safety.The company’s Pharmacovigilance Physician team operates across North America, Europe, and Asia, providing global pharmacovigilance services. PrimeVigilance is focused on creating a collaborative, high-quality environment for physicians interested in pharmacovigilance.

Role & Responsibilities• Perform ICSR case processing and safety data entry in Argus Safety Database within defined timelines• Download, triage, upload, and book-in regulatory and EMA MLM safety reports• Manage literature screening, case triaging, and safety data archiving• Ensure accurate MedDRA coding for all reported adverse events• Follow pharmacovigilance SOPs, processes, and global guidelines strictly• Communicate safety data requirements with internal and external stakeholders• Maintain compliance with global pharmacovigilance legislation and reporting timelines• Support aggregate reporting and signal management activitiesQualification• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related disciplinesExperience• 1–3 years of experience in Pharmacovigilance or Drug Safety• Hands-on experience with ICSR processing and Argus Safety Database preferredSkills• Strong knowledge of ICSR workflows, MedDRA coding, and regulatory reporting• Good understanding of GVP guidelines and global PV regulations• High attention to detail and quality-focused approach• Excellent written and verbal communication skills• Ability to manage multiple tasks and meet strict timelinesAbout the Company• Jubilant Pharma Limited is a global integrated pharmaceutical organisation, Operates USFDA-approved manufacturing and research facilities, Engaged in pharmaceuticals, generics, and drug safety operations.

Roles & Responsibilities• Manage Safety Data Exchange Agreements (SDEA) lifecycle• Prepare and maintain Pharmacovigilance System Master Files (PSMF)• Ensure compliance with PV Quality Management Systems• Coordinate with global safety teams• Act as Single Point of Contact (SPOC) for regional PV activities• Liaise with regulatory authorities and maintain inspection readiness• Support PV audits and inspections• Track and update safety documentation• Ensure compliance with local and global regulations• Support risk management activities and review PV processes for quality improvements• Collaborate with cross-functional stakeholders• Provide regulatory input for PV submissions• Maintain accurate PV records and logsQualification• B.Pharm or M.Pharm in Pharmacy, Pharmacology, Life Sciences, or related disciplineExperience• 5-10 years of experience in PharmacovigilanceVacancies• 1 VacancySkills• SDEA management• PSMF preparation and maintenance• PV Quality Management Systems• Global pharmacovigilance regulations• ROW regulatory knowledge• Signal detection awareness• Risk management planning• Audit readiness• Documentation compliance• Stakeholder coordinationAbout The CompanyDr. Reddy's Laboratories is a global pharmaceutical company committed to providing affordable and innovative medicines. Through its research, development, manufacturing, and commercialization, Dr. Reddy’s aims to make high-quality healthcare accessible across international markets.

Roles & Responsibilities• Lead safety case processing and support global safety evaluation activities• Monitor compliance with PVASC requirements for GSK and third parties including HSI reconciliation• Perform quality checks of adverse event reports in global safety databases and escalate issues• Maintain pharmacovigilance databases, EDMS, PVASC platforms, and shared systems• Collect, analyze, and document safety data from local operating companies• Generate standard safety listings and manage document archiving processes• Support regulatory inspections and internal audits under senior guidance• Contribute to SOPs, guidance documents, and process improvement initiatives• Collaborate with internal and external stakeholders with minimal supervisionQualification• Bachelor’s degree in life sciences, pharmacy, medicine, nursing, or related health scienceExperience• 5–9 years of pharmacovigilance or drug safety experience including ICSR processingSkills• Strong knowledge of pharmacovigilance regulations, GVP, and clinical safety documentation• Experience with safety databases and electronic case processing systems• Good understanding of medical terminology and MedDRA coding• Proficiency in MS Word, Excel, PowerPoint, SharePoint, and PowerBI• Strong organizational, analytical, and stakeholder management skillsAbout the CompanyGlaxoSmithKline (GSK) is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. GSK focuses on vaccines and specialty medicines to positively impact billions of patients worldwide while fostering a culture driven by integrity, innovation, and patient safety.

Roles & Responsibilities: • Perform end-to-end pharmacovigilance case processing for clinical trial safety cases • Collect, assess, process, and submit adverse event (AE) and serious adverse event (SAE) reports • Ensure timely and accurate data entry in LSMV (LifeSphere MultiVigilance) database • Maintain compliance with global pharmacovigilance regulations (ICH-GCP, GVP, FDA, EMA) • Support signal detection activities and risk management assessments • Collaborate with cross-functional teams on safety queries and investigations • Stay updated with current drug safety guidelines and industry standards Qualification: • Bachelor’s degree in Life Sciences, Pharmacy, or related discipline Experience: • Minimum 2+ years of experience in pharmacovigilance case processing • Hands-on experience in Clinical Trial Safety Cases OR LSMV / Argus / Safety Databases Skills: • Strong analytical skills with high attention to detail • Excellent written and verbal communication skills • Proven commitment to quality, compliance, and patient safety About the Organisation: ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing patient safety and delivering high-quality clinical development solutions across the pharmaceutical and biotech industries.