Pharmacovigilance Jobs in Hyderabad

Why This Role MattersPharmacovigilance plays a crucial role in safeguarding public health by ensuring the safe use of medicines and monitoring potential risks associated with pharmaceutical products. The role of a Pharmacovigilance Specialist focusing on ICSR Quality Review and Regulatory Submissions is vital in maintaining compliance with global safety regulations and ensuring that adverse event reports are accurately reviewed, processed, and submitted to health authorities within regulatory timelines.This position ensures that pharmaceutical companies meet their legal obligations for safety reporting while maintaining the highest standards of data quality and regulatory compliance. By reviewing Individual Case Safety Reports (ICSRs), approving submissions, and coordinating with internal safety teams, the specialist helps protect patient safety and supports the continuous monitoring of product safety profiles.Job DescriptionThe Pharmacovigilance Specialist – ICSR Quality Review & Regulatory Submissions is responsible for reviewing safety cases, ensuring accuracy and completeness of pharmacovigilance data, and approving regulatory submissions to health authorities. The role requires expertise in pharmacovigilance regulations, strong attention to detail, and hands-on experience with safety databases such as Argus.Working within a pharmacovigilance team, the professional ensures that safety cases meet global regulatory requirements before submission to health authorities, business partners, or affiliates. The role also involves coordinating regulatory timelines, ensuring compliance with pharmacovigilance guidelines, and supporting overall drug safety operations within the organization.Key Features of the Role:The role offers exposure to global pharmacovigilance regulatory frameworks and real-world safety data management. Professionals working in this position gain experience in regulatory submissions, quality review of safety cases, and health authority reporting obligations.The position also provides opportunities to collaborate with cross-functional teams including drug safety associates, regulatory affairs professionals, and quality assurance teams. This environment supports professional development in pharmacovigilance compliance, safety reporting systems, and global regulatory practices.ResponsibilitiesApprove and schedule safety reports in the Argus safety database for submission to relevant Health Authorities as per regulatory requirements.Review Individual Case Safety Reports (ICSRs) for quality, accuracy, and completeness before regulatory submission.Submit validated safety cases to Health Authorities, business partners, and affiliate organizations within required timelines.Ensure strict adherence to internal and external reporting timelines to maintain regulatory compliance.Schedule and approve regulatory reports according to country-specific reporting obligations and global pharmacovigilance guidelines.Perform quality checks to ensure data integrity, accurate coding, and compliance with pharmacovigilance standards.Collaborate with pharmacovigilance teams to resolve discrepancies and ensure proper documentation of safety reports.Support regulatory inspections, internal audits, and quality reviews related to pharmacovigilance processes.Required QualificationsEducational Requirements:Candidates should possess one of the following qualifications:B.Pharm (Bachelor of Pharmacy)M.Pharm (Master of Pharmacy)Experience and Skills:Candidates should have 4–6 years of relevant experience in Pharmacovigilance, particularly in ICSR Quality Review and Regulatory Submissions.Hands-on experience working with the Argus Safety Database is mandatory.Strong understanding of global pharmacovigilance regulations and health authority submission requirements.Experience in safety data review, regulatory reporting timelines, and pharmacovigilance compliance processes.Excellent analytical skills and attention to detail to ensure accuracy in safety case review.Strong communication skills to coordinate with internal teams and regulatory stakeholders.Ability to manage multiple priorities and meet strict regulatory deadlines.Salary InsightsThe salary for a Pharmacovigilance Specialist – ICSR Quality Review & Regulatory Submissions varies depending on experience, organization, and location.For professionals with 4–6 years of pharmacovigilance experience in India, the average annual salary typically ranges between ₹6 LPA and ₹12 LPA. Compensation may also include performance incentives, professional training opportunities, and career advancement within the drug safety domain.Company OverviewVizen Life Sciences Pvt. Ltd. is a pharmaceutical and life sciences organization focused on delivering high-quality services in pharmacovigilance, clinical research, and regulatory support. The company provides drug safety solutions to pharmaceutical companies by ensuring compliance with global pharmacovigilance standards and regulatory requirements.The organization emphasizes patient safety, regulatory excellence, and continuous improvement in drug safety monitoring systems. By integrating advanced safety databases and expert professionals, the company supports pharmaceutical partners in maintaining safe and effective medicines in the global healthcare market.FAQs1. What does an ICSR Quality Review Specialist do?An ICSR Quality Review Specialist checks Individual Case Safety Reports for accuracy, completeness, and compliance before submission to health authorities.2. What is the Argus Safety Database?Argus is a widely used pharmacovigilance database that helps manage adverse event reports, case processing, and regulatory submissions for pharmaceutical companies.3. Is pharmacovigilance experience mandatory for this role?Yes, candidates should have relevant pharmacovigilance experience, particularly in case processing, quality review, or regulatory submissions.4. What career growth opportunities exist in this field?Professionals can progress to roles such as Senior Pharmacovigilance Specialist, Drug Safety Manager, or Global Safety Lead.Application TipsHighlight your experience with pharmacovigilance databases such as Argus or similar safety systems.Emphasize your expertise in ICSR case review, regulatory reporting timelines, and global pharmacovigilance guidelines.Mention your ability to manage safety submissions under strict regulatory deadlines.Include any experience with regulatory audits, quality checks, or health authority interactions, as these are highly valued skills in pharmacovigilance roles.Tailoring your resume to showcase pharmacovigilance compliance knowledge and hands-on database experience will significantly increase your chances of securing this position.

Why This Role MattersDrug safety is a critical component of the pharmaceutical and healthcare industries. As medicines move through clinical development and into post-marketing use, continuous monitoring is required to ensure that they remain safe and effective for patients. Pharmacovigilance professionals play a key role in detecting, assessing, and preventing adverse drug reactions (ADRs), helping regulatory authorities and pharmaceutical companies maintain the highest safety standards.The Drug Safety Physician is responsible for providing medical expertise during the evaluation and management of safety data related to pharmaceutical products. This role involves performing detailed medical reviews of Individual Case Safety Reports (ICSRs), assessing causality and seriousness of adverse events, and ensuring compliance with global pharmacovigilance regulations. By carefully analyzing safety reports, the physician contributes to identifying potential risks and improving the benefit–risk profile of medications.In addition to reviewing individual safety cases, the Drug Safety Physician supports the preparation of aggregate safety reports such as Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), and Clinical Aggregate Safety Reports (CASRs). These reports are essential for regulatory submissions and ongoing drug safety monitoring. Through collaboration with pharmacovigilance teams, drug safety associates, and regulatory experts, the physician ensures that safety assessments are scientifically sound and compliant with international standards.Working in this role offers an opportunity to combine medical expertise with pharmacovigilance science, contributing directly to patient safety and global healthcare quality.Job DescriptionVizen Life Sciences Pvt Ltd is seeking a qualified Drug Safety Physician to join its pharmacovigilance and drug safety team. The role involves providing medical oversight and clinical expertise for pharmacovigilance case processing, safety data analysis, and aggregate safety reporting.The Drug Safety Physician will review Individual Case Safety Reports (ICSRs), assess causality and seriousness of adverse events, and ensure regulatory compliance with global pharmacovigilance standards. The role also involves mentoring drug safety associates, participating in signal detection activities, and contributing to safety review discussions with internal teams and clients.This position is ideal for medical professionals interested in pharmacovigilance, clinical safety evaluation, and regulatory drug safety monitoring within the pharmaceutical and life sciences industry.Key Features of the Role:• Job Title: Drug Safety Physician / Pharmacovigilance Medical Reviewer• Organization: Vizen Life Sciences Pvt Ltd• Industry: Pharmaceutical / Drug Safety / Pharmacovigilance• Employment Type: Full-Time• Functional Area: Pharmacovigilance Medical Review• Role Level: Medical Reviewer / Safety PhysicianResponsibilitiesMedical Review of Safety Cases• Perform detailed medical review and evaluation of Individual Case Safety Reports (ICSRs) and adverse drug reaction reports.• Assess seriousness, causality, and expectedness of reported adverse events.• Ensure completeness and medical accuracy of safety reports in accordance with global pharmacovigilance regulations.Case Handling and Safety Reporting• Provide medical guidance during the case handling and reporting cycle for investigational and marketed pharmaceutical products.• Ensure that case assessments meet regulatory reporting requirements and internal safety standards.• Support safety teams in the accurate interpretation of clinical and pharmacological information.Aggregate Safety Report Writing• Contribute to the preparation of safety sections for aggregate safety reports such as PSURs, CASRs, and PADERs.• Conduct benefit–risk assessments based on available safety data and clinical evidence.• Review and validate safety information included in regulatory submissions.Medical Guidance and Team Support• Provide expert guidance to Drug Safety Associates on medical aspects of pharmacovigilance case assessments.• Support team members in interpreting complex safety data and clinical information.• Mentor junior pharmacovigilance professionals involved in safety data processing.Signal Detection and Risk Evaluation• Analyze adverse drug reactions during ongoing safety surveillance activities.• Participate in signal detection processes to identify potential safety risks associated with pharmaceutical products.• Conduct independent evaluation of emerging safety signals and recommend further investigation when necessary.Safety Meetings and Client Interaction• Participate in safety review meetings with internal teams and external clients.• Provide medical insights and recommendations during safety discussions and decision-making processes.• Contribute to client presentations and safety evaluations related to pharmacovigilance activities.Audit and Regulatory Inspection Readiness• Maintain personal readiness for internal audits and regulatory inspections.• Ensure that safety documentation and medical evaluations comply with global regulatory standards.• Support the organization during pharmacovigilance inspections and compliance assessments.Required QualificationsCandidates applying for this role must possess a medical degree and a strong understanding of pharmacovigilance and drug safety processes. The role requires the ability to analyze clinical safety data, assess adverse events, and provide expert medical interpretation of pharmacovigilance information.Educational Requirements:Applicants should possess the following qualifications from a recognized institution:• MBBS (Bachelor of Medicine and Bachelor of Surgery)• MD in Pharmacology (preferred specialization)These qualifications provide the medical and pharmacological expertise required to evaluate safety data and interpret adverse drug reactions within the pharmacovigilance framework.Experience and SkillsExperience• Experience in pharmacovigilance, clinical research, or drug safety evaluation is preferred.• Prior experience reviewing ICSRs and participating in safety reporting processes is advantageous.• Exposure to aggregate safety reporting such as PSURs or PADERs is beneficial.Technical Skills• Strong knowledge of pharmacovigilance processes and ICSR management.• Understanding of global drug safety regulations and reporting requirements.• Ability to interpret clinical data and perform medical risk assessments.• Familiarity with pharmacovigilance databases and safety reporting tools.Professional Skills• Strong analytical and problem-solving abilities.• Excellent presentation and communication skills.• Ability to work collaboratively in multidisciplinary teams.• Client-focused approach to professional work.• Strong organizational and prioritization skills for managing multiple safety deliverables.Salary InsightsDrug Safety Physicians generally receive competitive compensation packages due to the specialized medical expertise required for pharmacovigilance roles. Salary levels vary depending on professional experience, medical specialization, and organizational structure.Professionals in this field may also benefit from career growth opportunities in global pharmacovigilance operations, regulatory affairs, clinical safety leadership, and medical affairs.Company OverviewVizen Life Sciences Pvt Ltd is a pharmaceutical and life sciences services company specializing in pharmacovigilance, regulatory affairs support, and clinical safety management. The organization works with pharmaceutical companies and healthcare organizations to ensure compliance with global drug safety standards. Through its expertise in pharmacovigilance operations, safety monitoring, and regulatory documentation, the company helps ensure that medicines are used safely and effectively across healthcare systems worldwide.FAQsWhat does a Drug Safety Physician do?A Drug Safety Physician reviews adverse event reports, evaluates safety data, and ensures regulatory compliance in pharmacovigilance processes.What are ICSRs in pharmacovigilance?Individual Case Safety Reports (ICSRs) are detailed reports documenting adverse events associated with pharmaceutical products.Is clinical experience required for this role?Clinical knowledge and understanding of pharmacology are essential, although specific clinical practice experience may vary depending on the employer.What are aggregate safety reports?Aggregate reports such as PSURs and PADERs summarize safety data collected over time to evaluate the overall benefit–risk profile of a drug.What career growth opportunities exist in pharmacovigilance for physicians?Physicians can advance to roles such as Senior Safety Physician, Medical Safety Lead, Pharmacovigilance Medical Director, or Global Safety Head.Application Tips• Highlight pharmacovigilance or clinical research experience in your resume.• Demonstrate expertise in ICSR medical review and safety data interpretation.• Mention experience with aggregate safety reports such as PSURs or PADERs.• Showcase strong analytical and medical writing skills.• Emphasize the ability to collaborate with pharmacovigilance teams and regulatory experts.

Why This Role MattersPharmacovigilance plays a vital role in ensuring the safety of medicines after they enter the market or during clinical development. Pharmaceutical and life sciences companies rely on pharmacovigilance professionals to monitor adverse drug reactions, analyze safety data, and ensure compliance with global regulatory requirements. These activities help protect patient health and support the safe use of medicines worldwide.The Drug Safety Associate is responsible for managing individual case safety reports (ICSRs), processing adverse event data, and maintaining accurate safety records within pharmacovigilance databases. By reviewing incoming safety reports, coding medical data, and preparing detailed case narratives, the associate contributes to maintaining high-quality safety documentation required by regulatory authorities.This role is particularly important because timely and accurate reporting of adverse events allows pharmaceutical companies and regulators to detect potential safety signals early. Professionals in pharmacovigilance operations work closely with global safety teams, regulatory affairs specialists, and medical reviewers to ensure that drug safety monitoring processes remain compliant and effective.Job DescriptionVizen Life Sciences Pvt Ltd is seeking a Pharmacovigilance professional to join its Drug Safety team. The role involves supporting pharmacovigilance case processing activities, including triaging incoming safety reports, data entry into safety databases, coding adverse events, and preparing case narratives.The Drug Safety Associate will be responsible for ensuring that safety information received from various sources is processed accurately and within regulatory timelines. The role also involves performing literature searches, managing follow-up queries for incomplete safety reports, and supporting regulatory compliance during audits and inspections.Working in this position provides an opportunity to gain hands-on experience in pharmacovigilance case processing, safety database management, medical coding, and global drug safety monitoring processes.Key Features of the Role:• Job Title: Drug Safety Associate / Pharmacovigilance Case Processing Associate• Organization: Vizen Life Sciences Pvt Ltd• Industry: Pharmaceutical / Drug Safety / Pharmacovigilance• Employment Type: Full-Time• Experience Required: 2–5 years• Functional Area: Pharmacovigilance OperationsResponsibilitiesCase Intake and Triage• Review and triage incoming safety reports for completeness, legibility, and validity.• Evaluate adverse event reports received from healthcare professionals, patients, or other sources.• Ensure that minimum safety information is present before initiating case processing.Case Data Entry and Processing• Perform booking and accurate data entry of Individual Case Safety Reports (ICSRs) into pharmacovigilance safety databases.• Verify the accuracy of safety information recorded in the database.• Ensure compliance with internal procedures and regulatory timelines.Follow-Up and Query Management• Request additional information when safety reports are incomplete or unclear.• Manage follow-up queries with reporters or internal teams to obtain missing safety data.• Track follow-up requests and update safety databases accordingly.Medical Coding and Data Classification• Perform coding of adverse events, medications, and medical history using standard medical dictionaries.• Ensure consistency and accuracy in coding to support safety signal detection and reporting.• Maintain standardized documentation practices in accordance with pharmacovigilance guidelines.Case Narrative Writing• Prepare clear and concise case narratives summarizing adverse event reports.• Ensure that narratives accurately reflect the sequence of events, patient information, and treatment outcomes.• Maintain high-quality documentation standards for regulatory review.Literature Monitoring• Conduct literature searches to identify published reports related to adverse drug reactions.• Evaluate relevant literature articles and extract safety information for pharmacovigilance reporting.• Maintain documentation of literature surveillance activities.Client Interaction and Meetings• Participate in client meetings and discussions related to pharmacovigilance case processing activities.• Provide updates on safety case management and operational deliverables when required.Audit and Inspection Support• Assist in preparation for pharmacovigilance audits and regulatory inspections.• Maintain documentation required for audit readiness.• Participate in audit discussions and support follow-up activities related to compliance findings.Required QualificationsCandidates applying for this role should have a background in pharmacy or pharmaceutical sciences with an understanding of pharmacovigilance operations and drug safety processes.Applicants should demonstrate analytical thinking, attention to detail, and strong communication skills to ensure accurate processing of safety data and collaboration with internal teams and clients.Educational Requirements:Candidates should possess one of the following qualifications from a recognized institution:• Bachelor of Pharmacy (B.Pharm)• Master of Pharmacy (M.Pharm)• Doctor of Pharmacy (Pharm.D)These qualifications provide the scientific knowledge necessary to understand drug safety concepts, adverse event reporting, and pharmacovigilance compliance requirements.Experience and Skills:Experience• Minimum 1–3 years of experience in pharmacovigilance, drug safety operations, or case processing.• Experience working with safety databases and pharmacovigilance workflows is preferred.• Exposure to adverse event reporting and safety documentation processes is advantageous.Technical Skills• Ability to perform database searches and literature reviews for safety monitoring.• Familiarity with pharmacovigilance safety databases and documentation systems.• Knowledge of medical terminology and adverse event reporting concepts.• Proficiency in Microsoft Office tools for documentation and reporting.Professional Skills• Strong analytical and problem-solving abilities.• Excellent written and verbal communication skills.• High attention to detail and accuracy in data entry and documentation.• Ability to work in a client-focused environment.• Capability to manage multiple safety cases and deadlines effectively.Salary InsightsDrug Safety Associates working in pharmacovigilance organizations typically receive competitive compensation packages based on their experience, technical expertise, and role responsibilities.Professionals in this field may also receive additional benefits such as performance bonuses, health benefits, training programs, and opportunities for career advancement within pharmacovigilance operations and regulatory safety departments.Company OverviewVizen Life Sciences Pvt Ltd is a pharmaceutical and life sciences service organization specializing in pharmacovigilance, regulatory support, and drug safety services. The company supports pharmaceutical organizations in managing safety data, ensuring regulatory compliance, and maintaining effective pharmacovigilance systems.By providing expert support in drug safety monitoring and regulatory compliance, the company contributes to improving the safe use of medicines and supporting global healthcare systems.FAQsWhat does a Drug Safety Associate do?A Drug Safety Associate processes adverse event reports, manages pharmacovigilance databases, and ensures compliance with regulatory safety reporting requirements.What type of reports are handled in this role?The role mainly involves processing Individual Case Safety Reports (ICSRs) and documenting adverse drug reactions reported by healthcare professionals or patients.Is pharmacovigilance experience required?Yes, basic experience in pharmacovigilance case processing, safety database management, or adverse event reporting is typically required.What skills are important for success in this role?Attention to detail, analytical thinking, medical writing skills, and strong communication abilities are essential.What are the career growth opportunities?Professionals can progress to roles such as Senior Drug Safety Associate, Pharmacovigilance Specialist, Safety Scientist, or Pharmacovigilance Manager.Application Tips• Highlight experience in pharmacovigilance case processing or adverse event reporting.• Mention familiarity with safety databases and medical coding processes.• Showcase strong documentation and case narrative writing skills.• Demonstrate ability to conduct literature searches and safety data analysis.• Emphasize attention to detail and ability to meet regulatory timelines.

Why This Role MattersPharmacovigilance professionals play a crucial role in ensuring the safety and effectiveness of medicines throughout their lifecycle. Within global pharmaceutical organizations, the monitoring and evaluation of drug safety data is essential for protecting patient health and maintaining regulatory compliance. Aggregate reporting and risk management activities help identify safety trends, evaluate benefit–risk profiles, and communicate critical safety information to regulatory authorities and healthcare stakeholders.In this role, the Pharmacovigilance Operations Associate supports the preparation, coordination, and quality review of aggregate safety reports and risk management deliverables. These reports are essential for regulatory submissions and ongoing safety monitoring of pharmaceutical products. By ensuring accurate documentation, compliance with regulatory guidelines, and timely report submission, the associate contributes directly to patient safety and global pharmacovigilance standards.Working with a leading pharmaceutical organization like Novartis provides exposure to advanced drug safety systems, global regulatory frameworks, and cross-functional collaboration within the pharmacovigilance ecosystem.Job DescriptionNovartis is seeking a Pharmacovigilance Operations Associate to support the Aggregate Reports and Risk Management (AR&RM) team within the Patient Safety and Pharmacovigilance (PS&PV) department. The role focuses on supporting the preparation, coordination, and tracking of pharmacovigilance deliverables related to aggregate safety reports and risk management documentation.The associate will assist in retrieving data from global safety databases, conducting quality checks of safety reports, managing report schedules, and ensuring regulatory compliance. The role also involves coordinating with internal teams and licensing partners, supporting project management activities, and maintaining documentation for audit and inspection readiness.This position is well suited for life sciences professionals who want to develop expertise in pharmacovigilance operations, safety reporting, regulatory compliance, and pharmaceutical risk management.Key Features of the Role• Job Title: Pharmacovigilance Operations Associate / Aggregate Reports & Risk Management Associate• Department: Patient Safety & Pharmacovigilance (PS&PV)• Organization: Novartis• Functional Area: Aggregate Reporting & Risk Management• Industry: Pharmaceutical & Drug Safety• Work Environment: Global pharmacovigilance operations teamResponsibilitiesAggregate Report Preparation• Support the preparation of assigned aggregate safety reports and risk management documentation.• Retrieve safety data from global pharmacovigilance databases according to company SOPs.• Assist in compiling data and preparing report sections for regulatory submission.Quality Review and Compliance• Perform quality control checks to ensure information presented in reports is accurate, complete, and consistent with source data.• Ensure reports comply with regulatory requirements, internal standards, and organizational templates.• Maintain proper documentation practices to support audit and inspection readiness.Operational Coordination• Support scheduling and coordination of AR&RM deliverables across product portfolios.• Coordinate report preparation timelines and ensure deadlines are met.• Assist with the dispatch and publication of assigned safety reports.Data Management and Tracking• Maintain tracking systems for AR&RM deliverables using internal tools and SharePoint platforms.• Collect and analyze data to prepare operational metrics and compliance reports.• Monitor performance indicators related to pharmacovigilance operations.Collaboration and Partner Coordination• Coordinate with licensing partners and internal stakeholders to ensure alignment on safety reporting responsibilities.• Facilitate document collection, distribution, and archiving of regulatory documents such as certificates and signatures.• Support communication activities through management of shared mailboxes.Audit and Inspection Support• Maintain documentation and records required for regulatory audits and inspections.• Support archival activities and documentation tracking to ensure compliance readiness.• Assist in preparation and follow-up of RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Action) activities.Automation and Operational Excellence• Participate in automation initiatives aimed at improving pharmacovigilance processes.• Support the implementation of advanced digital tools and artificial intelligence solutions for operational efficiency.• Assist in testing and validating pharmacovigilance safety systems and IT applications.Administrative and Operational Support• Manage inbound and outbound communications related to AR&RM operations.• Assist in preparation of compliance reports and quarterly updates for senior management and regulatory offices.• Support onboarding and training of new team members on AR&RM processes and systems.Required Qualifications• Bachelor’s Degree in Life Sciences, Pharmacy, or related healthcare discipline.• Basic understanding of pharmacovigilance processes and safety reporting requirements.• Familiarity with aggregate safety reporting and risk management processes is preferred.Educational RequirementsCandidates should possess one of the following qualifications from a recognized institution:• Bachelor’s Degree in Life Sciences• Bachelor’s Degree in Pharmacy or related healthcare discipline• Master’s Degree in Life Sciences or related fieldThese qualifications provide the scientific and regulatory foundation needed to understand drug safety monitoring, pharmacovigilance reporting, and regulatory compliance processes.Experience and SkillsExperience• Relevant experience in pharmacovigilance operations, drug safety reporting, or regulatory documentation is preferred.• Experience supporting aggregate safety reports or risk management activities is advantageous.Technical Skills• Familiarity with pharmacovigilance safety databases and reporting tools.• Knowledge of documentation management systems, SharePoint, and tracking tools.• Proficiency in Microsoft Office applications for reporting and data management.Professional Skills• Strong attention to detail and accuracy in documentation.• Good organizational and project coordination skills.• Ability to manage multiple deliverables and meet regulatory deadlines.• Strong communication and collaboration skills.• Commitment to compliance, quality, and regulatory standards.Salary InsightsPharmacovigilance operations professionals typically receive competitive compensation packages depending on experience, role complexity, and organizational structure. In large pharmaceutical companies, employees may also benefit from professional development programs, global exposure, and opportunities for career progression in drug safety and regulatory affairs.Company OverviewNovartis is one of the world’s leading pharmaceutical companies dedicated to reimagining medicine to improve and extend people’s lives. The company focuses on developing innovative medicines, advanced therapies, and cutting-edge healthcare solutions.With a strong global presence and a commitment to research and development, Novartis plays a vital role in advancing healthcare through scientific innovation. Its Patient Safety and Pharmacovigilance teams ensure that medicines meet the highest safety standards and comply with international regulatory requirements.FAQsQ1. What is the main responsibility of this role?The role focuses on supporting the preparation, tracking, and quality review of pharmacovigilance aggregate reports and risk management deliverables.Q2. What type of reports are handled in this role?The role supports aggregate safety reports, risk management documentation, and compliance reports related to pharmacovigilance activities.Q3. What skills are important for this position?Strong documentation skills, attention to detail, project coordination abilities, and knowledge of pharmacovigilance systems are essential.Q4. Does this role involve regulatory compliance?Yes, the role ensures that safety reports comply with regulatory requirements and organizational standards.Q5. What career growth opportunities are available?Professionals can progress to roles such as Senior Pharmacovigilance Associate, Safety Reporting Specialist, Risk Management Specialist, or Pharmacovigilance Manager.Application Tips• Highlight experience in pharmacovigilance, drug safety, or regulatory documentation.• Mention knowledge of aggregate safety reports and risk management processes.• Emphasize organizational and documentation management skills.• Demonstrate experience with compliance tracking and safety reporting tools.• Showcase the ability to manage multiple deliverables and meet strict regulatory timelines.

Why This Role MattersThe Executive / Senior Executive – Medical Affairs plays a strategic role in supporting scientific and clinical initiatives across emerging markets within the Cardio-Diabetes and Specialty therapeutic areas. This position ensures that medical strategies are grounded in robust clinical evidence, aligned with global guidelines, and compliant with regulatory standards.By providing accurate scientific inputs, supporting research initiatives, and engaging with key opinion leaders (KOLs), the role contributes to strengthening the company’s medical credibility and improving patient outcomes across international markets.Job DescriptionThe Medical Affairs Executive will support therapy-focused medical objectives, working closely with cross-functional teams including Marketing, Clinical, and R&D. The role involves scientific communication, training delivery, KOL engagement, and compliance oversight within a matrix organizational structure.Based in Hyderabad, the position reports to the Senior Manager – Medical Affairs and may involve international travel as required.Key Features of the Role• Position: Executive / Senior Executive – Medical Affairs• Therapy Area: Cardio-Diabetes / Specialty• Focus Region: Emerging Markets• Location: Hyderabad• Experience Required: 1–4 years• Industry: Pharmaceutical / Clinical Research• Travel: International travel as requiredKey ResponsibilitiesMedical & Scientific Support• Support Medical Affairs objectives for assigned therapy areas• Provide scientific and clinical inputs using current guidelines and clinical data• Support research activities and medical projects• Maintain accurate documentation of medical activitiesKOL & External Engagement• Assist in identification and engagement of KOLs and academic institutions• Present approved scientific data to healthcare professionals• Support external scientific collaborationsTraining & Medical Education• Support development and delivery of CMEs, advisory boards, and scientific meetings• Conduct medical training sessions for field force and internal teams• Ensure scientific accuracy and compliance of educational materialsCross-Functional Collaboration• Collaborate with Marketing, Clinical, R&D, and leadership teams• Support interdisciplinary projects within a matrix environmentCompliance & Governance• Ensure adherence to SOPs, ethical standards, and regulatory guidelines• Support medical review of promotional and educational materialsRequired QualificationsEducational Background:• Pharm D• M.Pharm• B.Pharm• BDS• Life Sciences qualificationExperience:• 1–4 years of experience in Medical Affairs, pharmaceutical industry, clinical research, or scientific communicationsTechnical Knowledge & Skills:• Understanding of pharmacology and clinical management of Cardio-Diabetes diseases• Ability to interpret and communicate clinical trial data and treatment guidelines• Strong medical writing and presentation skills• Effective verbal and written communication• Cross-functional collaboration skills• Proficiency in Microsoft Office and documentation toolsSalary InsightsCompensation will be aligned with industry standards for Medical Affairs professionals and may vary based on experience, therapeutic expertise, and international exposure.FAQsQ1. Is prior Medical Affairs experience mandatory?Experience in Medical Affairs or related pharmaceutical/clinical research roles is preferred.Q2. Does the role involve fieldwork?Yes, the role may involve external engagement and international travel when required.Q3. Is therapeutic area experience required?Knowledge of Cardio-Diabetes or Specialty therapy areas is preferred.Q4. Is this role office-based?The position is based in Hyderabad but may involve travel.Q5. Are freshers eligible?Candidates typically require 1–4 years of relevant experience.Application Tip• Highlight therapy area expertise in Cardio-Diabetes• Mention experience in KOL engagement or CMEs• Showcase clinical trial data interpretation skills• Include medical writing and presentation experience• Emphasize cross-functional collaboration exposure

Why This Role MattersPharmacovigilance is a critical function in the pharmaceutical and healthcare industry, ensuring patient safety through continuous monitoring of adverse events and compliance with global drug safety regulations. A Drug Safety Associate plays an essential role in maintaining regulatory timelines, processing safety data, and supporting global reporting obligations.This position is ideal for Life Sciences and Pharmacy graduates who want to build a long-term career in pharmacovigilance, regulatory affairs, or drug safety operations. It provides structured exposure to ICSR processing, safety submissions, regulatory intelligence, literature surveillance, and affiliate support activities. Working in a regulated safety environment helps professionals develop strong analytical thinking, documentation accuracy, and compliance discipline—core skills required in global clinical safety operations.Job DescriptionThe Drug Safety Associate will support global pharmacovigilance operations, including Individual Case Safety Report (ICSR) processing, safety submissions, literature monitoring, regulatory support, and affiliate coordination. The role requires adherence to global regulations, client-specific workflows, and internal Standard Operating Procedures (SOPs).The position involves monitoring safety data sources, ensuring accurate data capture in safety databases, maintaining compliance metrics, and supporting regulatory reporting activities. Associates are expected to follow structured workflows, maintain documentation integrity, and escalate issues appropriately.Key Features of the Role:• Exposure to global pharmacovigilance systems• Hands-on ICSR case processing experience• Involvement in regulatory submissions and compliance tracking• Opportunity to work with international health authorities• Learning and development through structured training modules• Participation in audits and inspections• Strong career pathway into senior safety and regulatory rolesResponsibilitiesGeneral Responsibilities• Develop knowledge of safety profiles, labeling, and global regulations• Follow project-specific workflows and procedures• Support compliance with regulatory reporting timelines• Assist in audit and inspection preparation• Review basic safety metrics and escalate issues• Maintain documentation and archiving standards• Participate in LMS training modules and complete assigned coursework• Ensure accurate and timely timesheet submissionICSR Processing• Monitor incoming safety reports from mailboxes, EudraVigilance, and literature sources• Perform literature searches and valid case data entry into safety databases• Triage incoming reports for completeness and validity• Request translations where required• Ensure medical cohesiveness and document consistency• Prepare ADR forms and coversheets• Perform MedDRA coding as per standard guidance• Conduct follow-up and query management• Prepare medically accurate case narratives• Perform quality and validation checks• Support compliance activities and late case investigations• Generate compliance metrics and support reconciliation activities• Perform database updates such as product additions or deletionsSafety Submissions• Submit ICSRs and periodic safety reports to regulatory authorities and ethics committees• Maintain reporting schedules and ensure timely submissions• Perform unblinding for safety reporting when required• Support development of global safety reporting procedures• Register products and organizations for electronic submissions• Track submission compliance and reporting quality• Prepare documentation within EDMS/eTMF systems• Participate in audits and inspections• Coach junior associates when applicableLiterature Search and Review• Develop and maintain search strategies based on client requirements• Screen scientific literature for potential ADRs and safety signals• Perform peer review of literature abstracts• Identify and forward safety signals for medical review• Maintain local journal lists and update search strategies• Insert full-text articles into databases where required• Coordinate with internal and external stakeholders to resolve search-related issuesAffiliate Services• Support communication between global safety teams and local affiliates• Maintain product information systems• Assist with translation and literature monitoring• Support local health authority interactions• Participate in reconciliation activities• Coordinate country-specific literature screeningRegulatory Support and Intelligence• Manage regulatory applications and lifecycle changes• Support global submissions including eCTD registrations and renewals• Track safety reports such as RMP, PBRER, and PASS• Maintain regulatory intelligence databases and trackers• Review country-specific safety reporting requirements• Collaborate with global pharmacovigilance intelligence teams• Ensure compliance with Service Level Agreements and KPIsRequired QualificationsCandidates must demonstrate foundational knowledge of pharmacovigilance processes and regulatory frameworks. Strong attention to detail, analytical ability, and documentation accuracy are essential. The role requires comfort working with structured databases and adherence to compliance-driven workflows.Educational Requirements:• Degree in Life Sciences, Health Sciences, or Biomedical Sciences• Pharmacy, Microbiology, Biochemistry, Biotechnology, or related disciplines preferred• Equivalent relevant qualification or work experience may be consideredExperience and Skills:• Foundational knowledge of drug safety regulations• Basic understanding of healthcare terminology• Familiarity with ICH guidelines and regional requirements (preferred)• Introductory exposure to pharmacovigilance databases• Basic proficiency in MS Office applications• Good communication and organizational skills• Strong willingness to learn and grow in drug safety operationsSalary InsightsCompensation is aligned with entry-level to junior pharmacovigilance roles in the healthcare industry. Salary may vary depending on experience, region, and organizational banding structure. Employees typically receive structured training, compliance exposure, and long-term growth opportunities within drug safety and regulatory domains.Company OverviewThe hiring organization operates within global pharmacovigilance and regulatory compliance frameworks, supporting sponsors and healthcare clients worldwide. The company maintains strict adherence to international drug safety standards, regulatory timelines, and quality benchmarks. Employees benefit from structured learning environments, exposure to global safety operations, and professional growth within clinical safety and regulatory affairs functions.FAQsIs prior pharmacovigilance experience mandatory?No, related healthcare experience is advantageous but not mandatory.What databases are commonly used in this role?Safety databases for ICSR processing and regulatory submission portals.Is this role suitable for fresh graduates?Yes, candidates with foundational knowledge and strong learning intent can apply.Does the role involve regulatory submissions?Yes, safety submissions to health authorities are a core responsibility.What career growth can be expected?Progression into Senior Drug Safety Associate, Safety Reporting Specialist, Regulatory Specialist, or PV Quality roles.Application Tips• Revise ICH-GCP and pharmacovigilance basics• Understand ICSR workflow and MedDRA coding fundamentals• Highlight internship or safety database exposure• Demonstrate attention to detail during interviews• Emphasize willingness to learn global safety regulations

Why This Role MattersAggregate Report Review Physicians are central to ensuring global product safety, regulatory compliance, and benefit-risk balance across the product lifecycle. By overseeing PSURs, PADERs, DSURs, RMPs, and signal management activities, this role directly impacts patient safety, labeling decisions, and regulatory confidence in marketed and developmental products.Job DescriptionViatris is hiring an Aggregate Report Review – Product Safety Physician (Pharmacovigilance) for its Hyderabad location (On-site, Full-Time). The Medical Reviewer will support global pharmacovigilance activities, ensuring compliance with international safety regulations and company standards. The role involves end-to-end oversight of aggregate safety reports, risk management strategies, signal evaluation, and health authority interactions.Key Features of the Role:• Location: Hyderabad, Telangana• Employment Type: Full-time (On-site)• Global pharmacovigilance exposure• Leadership in aggregate safety reporting• Collaboration with regulatory, clinical, and cross-functional teams• Senior-level safety oversight roleResponsibilities• Coordinate and conduct medical review of PSURs, PADERs, ACOs within regulatory timelines• Manage DSUR activities and collaborate with clinical safety teams• Develop safety strategies and safety management plans• Coordinate Risk Management Plan (RMP) preparation and medical review• Lead signal management activities including detection, validation, review, and escalation• Provide medical inputs for labeling, CCDS, and RSI updates• Prepare responses to Health Authority safety queries• Represent clinical safety perspective in oversight committees• Train team members on assigned therapeutic portfolios• Support PV Quality Management Systems and departmental projects• Develop and update SOPs• Escalate and track critical safety issues until resolution• Maintain updated knowledge of global pharmacovigilance regulationsRequired Qualifications• MBBS (mandatory)• MD (preferred)• Minimum 8 years of aggregate report review experience• Minimum 10 years pharmaceutical industry experience• Strong knowledge of pharmacovigilance guidance and global regulationsEducational Requirements:• MBBS (mandatory)• MD (preferred)Experience and Skills:• Extensive experience in PSUR, PADER, DSUR, RMP preparation and review• Strong understanding of signal management processes• Expertise in labeling documents (CCDS, RSI)• Health Authority interaction experience• Leadership and team training capability• Cross-functional collaboration skills• Strong analytical and medical judgment abilityAge Eligibility:As per company normsSalary InsightsCompensation not disclosed. Senior-level industry remuneration expected based on experience and expertise.Company OverviewViatris is a global pharmaceutical company committed to expanding access to high-quality medicines worldwide. With a diversified portfolio spanning branded medicines, generics, and complex generics, Viatris focuses on sustainable healthcare solutions through access, leadership, and partnership.FAQsIs aggregate report experience mandatory?Yes, a minimum of 8 years of aggregate report review experience is required.Is MD mandatory?MD is preferred but MBBS is mandatory.Does the role include signal management?Yes, signal detection, validation, and escalation are core responsibilities.Is this a remote role?No, this is an on-site role based in Hyderabad.Will the role involve Health Authority interactions?Yes, preparation and review of regulatory responses are included.Application Tips• Clearly highlight aggregate report review experience (PSUR, DSUR, PADER, RMP)• Mention experience with CCDS/RSI updates• Showcase leadership and training experience• Demonstrate signal management expertise• Emphasize regulatory interaction and global PV exposure

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.

Role & Responsibilities• Manage end-to-end MICC (Medical Information & Call Center) operations within Pharmacovigilance• Oversee PV case intake, triage, and ICSR processing as per global regulatory guidelines• Ensure compliance with SOPs, SLAs, and global regulatory requirements (FDA, EMA, ICH)• Review and monitor ICSR cases for quality, accuracy, and timely submissions• Handle escalations, client communications, and internal stakeholder coordination• Train, mentor, and supervise MICC team members• Prepare and present performance metrics, quality reports, and audit documentation• Support regulatory inspections and audits as requiredQualification• M.Pharm / Pharm.D / B.Pharm / Life Sciences (relevant qualification preferred)Experience• 6–7 years of Pharmacovigilance experience• Strong exposure to MICC / Call Center PV operations• Experience in team management and stakeholder coordinationSkills• In-depth knowledge of ICSR processing and MedDRA coding• Hands-on experience with global safety databases• Strong understanding of FDA, EMA, and ICH regulatory guidelines• Leadership and team supervision skills• Excellent communication and client management abilities• Ability to work in night shift (9:00 PM – 6:00 AM IST)About the CompanyMitocon Biopharma operates within the pharmacovigilance and drug safety domain, delivering MICC and global PV operations support to pharmaceutical clients. The organization provides leadership opportunities, exposure to international regulatory standards, and a dynamic work environment focused on quality, compliance, and operational excellence in Hyderabad.

Roles & Responsibilities:• Manage Product Life Cycle Management (LCM) activities in line with regulatory guidelines• Ensure compliance with applicable regulatory requirements and internal SOPs• Maintain and update internal regulatory databases and tracking systems• Keep regulatory archives updated with valid licenses, approvals, and labelling documents• Coordinate with internal and external stakeholders for change management activities• Assist in electronic formatting and compilation of global regulatory submissions (eCTD)• Support preparation and review of global filing documentation as per agency guidance• Perform documentation control, archival, and administrative regulatory tasks• Support regulatory submissions in compliance with ICH and EU requirementsQualification:• Bachelor degree in Pharmacy, Master of Pharmacy• Bachelor’s Degree in Science from a reputed College/UniversityExperience:• 2–3 years of experience in Regulatory Affairs or regulated pharmaceutical industrySkills:• Knowledge of Product Lifecycle Management (PLM)• Understanding of EU regulatory requirements and ICH guidelines• Experience in eCTD submissions and electronic publishing• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)• Strong documentation, tracking, and archival skills• Familiarity with regulatory software systems• Ability to work independently and collaboratively in cross-functional teams• Fluency in English (written and verbal communication)About the Organization:Orion Pharma is a globally operating pharmaceutical organization focused on delivering innovative and high-quality medicines while maintaining strong regulatory compliance across international markets.

Roles & Responsibilities:• Compile, review, and author CTD and eCTD dossiers for global submissions• Perform eCTD publishing and manage submission sequences and lifecycle operations• Handle product lifecycle activities including variations, renewals, amendments, and compliance updates• Ensure compliance with current regulatory guidelines and country-specific requirements• Coordinate with QA, CMC, Clinical, Pharmacovigilance, and Medical Writing teams• Communicate with Health Authorities and manage deficiency responses• Track submission timelines, approvals, and regulatory commitments• Maintain regulatory databases and documentation• Support audits, inspections, and internal regulatory assessmentsQualification:• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related disciplineExperience:• 4–6 years of experience in Regulatory Affairs (Pharma/Life Sciences)• Strong hands-on experience in CTD and eCTD compilation and publishing• Experience with US, EU, and ROW regulatory submissions• Experience in lifecycle management and Health Authority interactionsSkills:• Strong knowledge of global regulatory frameworks• eCTD publishing expertise• Good documentation and communication skills• Ability to manage multiple submissions independently• Detail-oriented with compliance-focused mindsetAbout the Organization:Medifodil Smart Pharma Solutions provides regulatory consulting and dossier management services, supporting global pharmaceutical companies in regulatory submissions and product lifecycle management across multiple markets.

Roles & Responsibilities• Perform medical review of ICSRs including narratives, coding, expectedness, causality, and seriousness assessment• Ensure medical validity and produce accurate, high-quality ICSR reports• Conduct case escalation and follow-up activities as per SOPs• Assess reportability for medical device and product complaint-related events• Act as medical point of contact for Case Management teams• Support medical coding standards and continuous process improvements• Contribute to SOP development, metrics tracking, and cross-functional initiatives• Maintain inspection readiness and support Health Authority inspections and internal audits• Undertake delegated QPPV activities as per PV System Master FileQualification• MD / DO or international equivalent (Mandatory)Experience• Minimum 1 year of related drug safety experience (Basic requirement)• 3+ years of relevant pharmacovigilance experience preferredSkills• Strong knowledge of pharmacovigilance regulations and ICSR medical review• Understanding of clinical trials and post-marketing safety• Proficiency in safety databases and medical coding systems• Clinical knowledge of therapeutic areas and drug classes• Strong analytical, documentation, and compliance skillsAbout the OrganizationAmgen is a global biotechnology company committed to discovering and developing innovative therapies. Through its Global Patient Safety team, the organization ensures high pharmacovigilance standards to protect patients worldwide.

Roles & Responsibilities• Ensure high-quality processing of Individual Case Safety Reports (ICSRs) for device and combination products• Oversee vendors for case intake, processing quality, and performance metrics• Submit safety reports to FDA, EMA, and other global regulatory authorities• Act as US/EU local safety office contact point for device safety matters• Manage safety reporting timelines for clinical trial and post-market cases• Support PASR (Periodic Aggregate Safety Reports) activities• Ensure compliance with global GVP, GMP, and internal SOP requirements• Support audit and inspection readiness under QPPV delegation• Maintain documentation and compliance within the Quality Management System (QMS)Qualification• Doctorate + 4 years of Drug Safety/Life Sciences experience OR• Master’s degree + 7 years of Drug Safety/Life Sciences experience OR• Bachelor’s degree + 9 years of Drug Safety/Life Sciences experienceExperience• Strong experience in Pharmacovigilance, Drug Safety, or Device Safety• Experience in ICSR processing for device or combination products• Exposure to regulatory submissions (FDA, EMA)• Vendor management and compliance oversight experience preferredSkills• In-depth knowledge of global pharmacovigilance regulations• Strong understanding of device and combination product safety reporting• Experience with safety databases and intake systems• Attention to detail and regulatory accuracy• Proficiency in MS Office (Excel, Word, PowerPoint, Outlook)• Ability to work effectively in a global matrix environment• Strong analytical and problem-solving skillsAbout the OrganizationAmgen is a global biotechnology leader focused on innovative therapies for serious illnesses, operating with strong regulatory compliance, scientific excellence, and patient-centric safety standards across global markets.

Roles & Responsibilities• Monitor and route incoming safety information to appropriate project teams• Record and track ICSR documentation as per sponsor/customer specifications• Perform accurate and timely data entry into safety databases• Process Literature and Clinical Trial (CT) cases as per regulatory guidelines• Redact patient-identifying information in compliance with ICH-GCP and GVP requirements• Assist in case file creation, tracking, reconciliation, and maintenance (electronic & paper)• Support safety submissions and query follow-up activities• Manage translation processes for source safety documents• Maintain compliance with SOPs, WIs, global PV regulations, and study plansQualification• B.Pharm / M.Pharm / PharmD / BDSExperience• Minimum 1 year of Pharmacovigilance experience in full data entry/case processing role (mandatory)• Experience in Literature and Clinical Trial (CT) case processing preferred• Exposure to safety databases and medical terminology preferredSkills• Strong knowledge of pharmacovigilance and ICSR processing• Understanding of ICH-GCP, GVP modules, and global safety regulations• Proficiency in MS Office and document management systems• Excellent written and verbal communication skills• High attention to detail and documentation accuracy• Ability to manage multiple tasks in a fast-paced environment• Strong teamwork and organizational skills• Flexibility to work in rotational shiftsAbout the OrganizationSyneos Health® is a leading fully integrated biopharmaceutical solutions organization operating in over 110 countries with 29,000+ employees. The company supports clinical development and commercialization, contributing to 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products in recent years, accelerating therapies that change lives worldwide.

Roles & Responsibilities• Support PV system compliance and SOP implementation• Conduct quality checks and internal audits• Assist in inspection readiness and CAPA tracking• Maintain pharmacovigilance quality standardsQualification• B.Pharm, M.Pharm, Pharm.D, Msc, BSc, or other Lifesciences degreeExperience• 4–6 years of relevant pharmacovigilance experienceSkills• Strong understanding of global pharmacovigilance regulations (ICH, GVP, FDA, EMA guidelines)• Experience with safety databases (Argus/ArisG preferred)• Strong analytical and documentation skills• Ability to work in a compliance-focused, quality-driven environmentAbout The CompanyMedifodil Smart Pharma Solutions is an expanding pharmacovigilance department offering high-growth opportunities in a quality-driven environment. With a focus on regulatory compliance and patient safety, Medifodil provides comprehensive solutions across ICSR, aggregate reporting, and PV Quality Assurance (QA).

Roles & Responsibilities• End-to-end ICSR case intake, processing, follow-up, and regulatory submissions• Provide medical review support and narrative writing• Perform MedDRA coding and case quality checks• Ensure compliance with global reporting timelines (FDA, EMA, MHRA)Qualification• B.Pharm, M.Pharm, Pharm.D, Msc, BSc, or other Lifesciences degreeExperience• 4–6 years of relevant pharmacovigilance experienceSkills• Strong understanding of global pharmacovigilance regulations (ICH, GVP, FDA, EMA guidelines)• Experience with safety databases (Argus/ArisG preferred)• Strong analytical and documentation skills• Ability to work in a compliance-focused, quality-driven environmentAbout The CompanyMedifodil Smart Pharma Solutions is an expanding pharmacovigilance department offering high-growth opportunities in a quality-driven environment. With a focus on regulatory compliance and patient safety, Medifodil provides comprehensive solutions across ICSR, aggregate reporting, and PV Quality Assurance (QA).

Roles & Responsibilities• Monitor and route incoming safety information to project teams• Perform accurate ICSR data entry and case processing in safety databases• Track and record all safety documentation per sponsor guidelines• Redact patient-identifiable data as per ICH-GCP and GVP requirements• Support literature and clinical trial (CT) case processing• Assist in translation coordination for safety source documents• Support query follow-up and safety submission processes• Maintain case files (electronic and paper)• Conduct daily workflow reconciliation activities• Follow SOPs, WIs, global PV regulations, and study plansQualification• B.Pharm / M.Pharm / PharmD / BDSExperience• Minimum 1 year of Pharmacovigilance case processing or full data entry role (mandatory)• Experience in Clinical Trial (CT) cases and Literature cases preferred• Knowledge of safety databases and medical terminology preferredSkills• Strong documentation accuracy• Ability to manage multiple tasks• Team collaboration• MS Office (Word, Excel, PowerPoint, Outlook) proficiency• Familiarity with document management systems• Understanding of ICH Guidelines, GVP Modules, and global drug safety regulationsAbout The CompanySyneos Health is a global, mid-sized Contract Research Organization (CRO) providing integrated biopharmaceutical solutions to help customers accelerate the development of their drugs. With operations in over 110 countries, Syneos Health has been involved in 94% of novel FDA-approved drugs in the last five years, offering unparalleled exposure to global regulatory standards and drug safety regulations.

Roles & Responsibilities• Support regulatory services activities aligned with Life Sciences R&D operations• Coordinate documentation and resources required for global regulatory submissions• Manage and process electronic submissions, including original applications and lifecycle management submissions• Handle submissions related to CMC, advertising and promotional materials, amendments, annual reports, and SPL submissions• Prepare, review, and maintain regulatory documentation in compliance with applicable laws and regulations• Assist in regulatory reporting and submissions to health authorities• Stay updated with changing regulatory guidelines and support compliance audits• Perform analysis and resolution of low to medium complexity regulatory problems• Interact primarily with internal Accenture peers and update supervisors on work progress• Follow detailed instructions for new assignments and moderate guidance for daily tasks• Ensure decisions made are accurate and maintain quality standards, impacting own work and team deliverables• Work as an individual contributor within a team-focused environment• Be flexible to work in rotational shifts as requiredQualification• Bachelor of Pharmacy (B.Pharm)Experience• 3 to 5 years of experience in Life Sciences Regulatory Operations or Regulatory Services• Hands-on exposure to global regulatory submissions and electronic publishing processesSkills• Strong understanding of life sciences regulatory requirements and submission processes• Ability to work effectively in a team-oriented environment• Adaptable and flexible to changing project needs• High commitment to quality and compliance• Good analytical and problem-solving skills• Basic understanding of regulatory lifecycle management and compliance auditsAbout the CompanyAccenture is a global professional services company with expertise in digital, cloud, and security. With over 784,000 professionals across 120+ countries, Accenture delivers strategy, consulting, technology, and operations services to help organizations drive innovation, improve outcomes, and create sustainable value across industries, including life sciences and healthcare.

Roles & Responsibilities• Serve as primary point of contact between Sponsor and JSTL for clinical trial projects• Develop and manage Master Service Agreements (MSA) in coordination with Sponsors• Provide guidance on MSA terms to all Functional Leads• Develop and maintain SOPs for clinical trial project management• Lead project initiation involving Sponsors, Functional Leads, CRAs, Investigators, and site staff• Supervise CRAs in site selection, contracts, budget negotiations, and regulatory submissions• Oversee site start-up, monitoring, execution, and close-out activities• Ensure compliance with national/local regulations, ICH-GCP guidelines, and JSTL SOPs• Monitor regulatory updates and ensure implementation of changes impacting clinical trials• Ensure audit and inspection readiness of sites and follow-up on audit findings• Manage project timelines, milestones, budgets, and resource allocation• Provide periodic project assessments and progress reports to Sponsors and leadership• Maintain MSAs and project metrics using Microsoft management tools• Manage internal and external resources including vendors and third-party contractors• Support hiring, training, performance management, and retention of clinical operations staffQualification• Master’s degree in Life Sciences• Advanced degree (MS Pharmacy / PharmD / PhD / MD) preferred• Certification in Clinical Trial Project Management preferredExperience• 3–5 years of experience in clinical trial project management• Experience managing Phase I–IV clinical trials preferred• Prior experience in CRO or pharmaceutical industry desirableSkills• Strong written and verbal communication skills• Excellent stakeholder and sponsor management capabilities• Strong planning, organizational, and multitasking abilities• Ability to work independently in a regulated, patient-focused environment• Strong analytical, critical thinking, and decision-making skills• Ability to manage cross-functional and diverse teams with integrity• Proficiency in Microsoft Project Manager and related IT tools for metrics and reportingAbout the OrganizationJeevan Scientific Technology Limited is a global life sciences services organization providing integrated solutions in clinical research, regulatory affairs, project management, pharmacovigilance, and medical writing, supporting pharmaceutical and biotech companies across the full clinical development lifecycle.

Roles & Responsibilities• Collect, review, and process Adverse Event (AE) and Serious Adverse Event (SAE) reports• Perform case processing and data entry in drug safety databases• Ensure accuracy, completeness, and timeliness of safety case documentation• Conduct literature search and review for safety-relevant information• Assist in signal detection, risk assessment, and safety evaluations• Support preparation and submission of safety reports such as PSURs and DSURs• Ensure compliance with ICH-GCP, ICH-E2B, and global regulatory guidelines• Coordinate with cross-functional teams including Clinical, Regulatory, and Quality• Maintain safety records and support audit and inspection readinessQualification• Bachelor’s degree in Pharmacy, Life Sciences, Nursing, or a related disciplineExperience• 0 to 2 years of experience in Pharmacovigilance or Drug Safety• Freshers with relevant academic knowledge may also applySkills• Basic knowledge of pharmacovigilance and drug safety concepts• Understanding of AE/SAE reporting and regulatory requirements• Good written and verbal communication skills• Strong attention to detail and analytical skills• Ability to work independently and in a team environment• Proficiency in MS Word, Excel, and safety databases is an advantageAbout the OrganizationJeevan Scientific Technology Limited is a leading life sciences and healthcare solutions company offering services across pharmacovigilance, clinical research, regulatory affairs, and data management. The organization supports global pharmaceutical and biotech companies with high-quality, compliant, and technology-driven solutions.