We are looking for a candidate with around 4-5 years of experience in pharmacovigilance and drug safety evaluation with strong expertise in signal detection, risk management, and safety analysis.

Key Responsibilities:

1. Independently manage and evaluate individual case safety reports (ICSRs), ensuring thorough assessment of adverse drug reactions (ADRs).

2. Maintain detailed and accurate records of data entry activities of adverse event details in Pharmacovigilance database.

3. Handling of Medical Information Queries like Adverse Event, Product Quality Complaint etc. by telephonic calls, email, social media and other sources.

4. Perform in-depth clinical review of adverse events to establish causality, severity, and outcome.

5. Contribute to the preparation and review of Risk Management Plans (RMPs), Risk Minimization Strategies, and Risk Benefit Assessments and ensure that identified risks are documented, communicated and tracked until mitigation or resolution.

6. Prepare and review of safety reports, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), SDEA, and aggregate reports.

7. Perform quantitative and qualitative evaluations of safety data base using advanced pharmacovigilance software and tools (e.g., ARGUS).

8. Ensuring and verifying that the Pharmacovigilance System Master File (PSMF) is constantly an accurate and up-to-date reflection of that safety system.

9. Development and implementation of internal procedures, workflows, and standard operating procedures (SOPs).

10. Ensure that all AE reports are processed and submitted in a timely manner to regulatory authorities and in compliance with applicable guidelines (e.g., ICH, FDA, EMA).

11. Participate in signal detection activities, to identify potential safety signals from pharmacovigilance data.

12. Ensure accurate and consistent medical coding through MedDRA (medical dictionary for regulatory activities) for all events in Pharmacovigilance database.

13. Ensure compliance with local, regional, and global pharmacovigilance regulations and guidelines (e.g., GVP, FDA, EMA).

14. Lead or oversee a team of junior pharmacovigilance staff, providing training, mentorship, and guidance on case processing, safety assessments, and regulatory reporting.

15. Conduct training sessions to ensure team members are up to date on the latest pharmacovigilance practices and regulations.

16. Work closely with Clinical Development, Medical Affairs, Regulatory Affairs and other departments to ensure accurate and timely safety reporting.

17. Conduct in-depth analysis of adverse event data, identifying trends, signals and potential risks.

18. Prepare for and support regulatory audits, inspections, and internal audits by ensuring that all safety data and documentation is in compliance.

Required Skills & Qualifications:

- Educational Requirements:

- B. Pharm. or M. Pharm. in Pharmacology.

- Technical Skills:

- In-depth knowledge of pharmacovigilance regulations, including ICH E2E guidelines, GVP and ICSR reporting standards.

- Working experience in the the Clinical research Industry is mandatory.

Notice Period: Immediate joiner will be preferred or up to 30 days- notice period.