Amgen is hiring a Senior Associate – Pharmacovigilance Operations for its Medical Services team in Hyderabad, India. This full-time, on-site role offers an excellent opportunity for experienced pharmacovigilance professionals to work on US/EU safety reporting, ICSR submissions, and global regulatory compliance in a highly regulated environment.
The role plays a critical function as a local safety office representative and FDA/EMA point of contact, ensuring high-quality case processing, vendor oversight, and inspection readiness in line with global pharmacovigilance regulations.
Key Responsibilities – Pharmacovigilance Operations
- Act as US/EU local safety office and FDA/EMA point of contact
- Submit Individual Case Safety Reports (ICSRs) to FDA, EMA, and business partners
- Perform case review, quality checks, and escalation of case-level issues
- Ensure timely expedited safety reporting as per regulatory timelines
- Support vendor oversight for case intake, triage, processing, and quality metrics
- Conduct reportable event reconciliation for Amgen-sponsored clinical trials
- Support business partner (BP) reconciliation per safety agreements
- Manage intake, triage, and data entry queries related to ICSRs
- Provide LAO E2B support including nullification and redistribution
- Support audit readiness, health authority inspections, and internal audits
- Undertake delegated activities from the QPPV as per PV System Master File
- Assist in pharmacovigilance training delivery and convention-related training
Key Activities
- Review non-matching safety data across clinical and safety databases
- Oversee vendor clinical safety reconciliation teams
- Perform US case follow-up activities
- Select cases for FDA/EMA reporting based on legislation and contracts
- Initiate unblinding requests when required
- Support ICSR literature review processes
- Ensure compliance with global pharmacovigilance regulations
Qualifications & Experience
Education & Experience (Any One):
- Bachelor’s degree + 2 years of pharmacovigilance experience
- Associate’s degree + 6 years of directly related experience
- High school diploma/GED + 8 years of pharmacovigilance experience
Required Skills:
- Strong understanding of global pharmacovigilance regulations
- Experience in ICSR case processing and reporting
- Familiarity with clinical development processes
- High attention to detail and case quality
- Proficiency in safety databases and Microsoft Office (Word, Excel, PowerPoint, Outlook)
Why Join Amgen?
- Work with a global biopharmaceutical leader
- Exposure to FDA & EMA safety reporting
- Strong focus on quality, compliance, and inspection readiness
- Career growth in global pharmacovigilance operations
- Competitive salary and professional work environment
Salary (Estimated)
₹8,00,000 – ₹12,00,000 per annum (based on experience and industry standards in India)
Job Location
📍 Hyderabad, Telangana, India
(On-site role)
How to Apply
