Amgen is a global biotechnology leader committed to innovative therapies for serious illnesses. With a strong focus on patient safety and regulatory compliance, Amgen offers dynamic career opportunities in pharmacovigilance and drug safety.
Job Description: Sr. Associate Pharmacovigilance Operations
Key Responsibilities:
✔ Authoring & Compiling Periodic Aggregate Safety Reports (PASRs)
- DSUR, PBRER/PSUR, SSUR, PADER/PAER, Device PSUR, and country-specific reports (e.g., Korea PSUR, Brazil PSUR).
✔ Stakeholder Coordination - Schedule cross-functional meetings, manage timelines, and escalate risks.
✔ Safety Content Writing - Collaborate with Therapeutic Area Safety Scientists to draft safety sections.
✔ Quality Control & Compliance - Conduct peer QC, manage approvals, and ensure adherence to regulatory guidelines.
✔ Report Distribution - Handle distribution to CROs (Contract Research Organizations) and Business Partners (BPs).
✔ Metrics & Compliance Tracking - Generate Key Compliance Indicators (KCIs) & Key Performance Indicators (KPIs).
Additional Responsibilities (if required):
- Assist with Literature Management processes.
Eligibility & Qualifications
✅ Education: Bachelor’s or Master’s in Life Sciences/Pharmacy.
✅ Experience:
- Total: 5–9 years
- Periodic Report Writing: 2–3 years (mandatory)
✅ Skills Required: - Strong regulatory knowledge (ICH, GVP, FDA/EMA guidelines).
- Expertise in pharmacovigilance operations & safety reporting.
- Excellent scientific writing & peer review abilities.
Benefits of Working at Amgen
✨ Competitive Salary & Bonus
✨ Health & Wellness Programs
✨ Career Growth in Global Biotech
✨ Work-Life Balance (Hybrid Options)
✨ Learning & Development Opportunities
How to Apply
