Pfizer is a leading global biopharmaceutical company committed to delivering breakthrough therapies that improve patients’ lives. With a legacy of innovation, Pfizer focuses on vaccines, oncology, internal medicine, and rare diseases. The company fosters a diverse and inclusive workplace, encouraging professional growth and development.
Job Title: Associate – Safety Data Management Specialist
Location: Chennai, India (Hybrid)
Job ID: 4938187
Posted: Today
Key Responsibilities
As a Safety Data Management Specialist, you will:
✔ Process and review Individual Case Safety Reports (ICSR) for accuracy and compliance.
✔ Assess case validity, seriousness, and regulatory reportability.
✔ Write and edit case narratives, ensuring data consistency.
✔ Perform follow-ups on cases, including generating queries.
✔ Collaborate with global teams for data reconciliation.
✔ Stay updated on global pharmacovigilance regulations and Pfizer SOPs.
✔ Support audits and inspections related to safety data.
Eligibility Criteria
- Education: B.Pharm / M.Pharm / Pharm.D only.
- Experience: 1-2 years in end-to-end ICSR processing (including listedness assessment).
- Preferred Skills:
- Experience with ARGUS safety database.
- Knowledge of E2B R2/R3 (XML) case processing.
- Strong understanding of medical terminology & regulatory requirements.
Why Join Pfizer?
✅ Hybrid work model (flexible office & remote work).
✅ Competitive salary & benefits (health insurance, bonuses).
✅ Global exposure in pharmacovigilance.
✅ Learning & career growth opportunities.
✅ Inclusive & diverse workplace culture.
