Global biotechnology leader Amgen is currently recruiting for the position of Sr. Associate Pharmacovigilance Operations at its Hyderabad office. This is an excellent opportunity for professionals seeking to build a career in pharmacovigilance operations, aggregate safety reporting, drug safety, and regulatory compliance within a leading multinational biopharmaceutical company.
The role focuses on the preparation, review, and management of Periodic Aggregate Safety Reports (PASRs), ensuring compliance with global regulatory requirements and supporting patient safety initiatives worldwide.
Job Overview
- Company: Amgen
- Position: Sr. Associate Pharmacovigilance Operations
- Job Location: Hyderabad, Telangana, India
- Job Type: Full-Time
- Department: Safety / Pharmacovigilance
- Work Mode: On-Site
- Job Requisition ID: R-246911
- Posted Date: June 11, 2026
Key Responsibilities
The selected candidate will support the end-to-end preparation and management of aggregate safety reports and pharmacovigilance documentation.
Aggregate Safety Reporting
- Compile and author Periodic Aggregate Safety Reports (PASRs)
- Prepare and support Development Safety Update Reports (DSURs)
- Contribute to Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Support Periodic Safety Update Reports (PSURs)
- Assist with Semi-Annual Safety Update Reports (SSURs)
- Prepare Periodic Adverse Drug Experience Reports (PADER/PAER)
- Support Device PSURs and country-specific safety reports
Cross-Functional Collaboration
- Coordinate meetings with internal stakeholders and business partners
- Track report timelines and escalate risks when required
- Collect safety data contributions from multiple functions
- Collaborate with Therapeutic Area Safety Scientists
Quality Review & Compliance
- Conduct peer quality control reviews of safety sections
- Resolve review comments and support approval workflows
- Ensure compliance with global pharmacovigilance regulations
- Maintain report documentation and audit-ready records
- Review published report versions before final distribution
Reporting & Metrics
- Generate Key Compliance Indicators (KCIs)
- Develop Key Performance Indicators (KPIs)
- Support pharmacovigilance process improvements
- Contribute to literature management activities as required
Preferred Qualifications
Candidates with the following qualifications are encouraged to apply:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Biochemistry, Microbiology, Clinical Research, or related disciplines
- Experience in pharmacovigilance operations or aggregate safety reporting
- Understanding of global regulatory guidelines and safety reporting requirements
- Strong medical writing and documentation skills
- Excellent stakeholder management and communication abilities
- Ability to manage multiple projects and timelines effectively
- Familiarity with DSUR, PSUR, PBRER, PADER, and related safety reports
Why Join Amgen?
Amgen is recognized globally for innovation in biotechnology and patient-focused healthcare solutions. Employees benefit from:
- Opportunity to work on global pharmacovigilance programs
- Exposure to international regulatory submissions
- Collaborative cross-functional work environment
- Career growth in drug safety and risk management
- Learning opportunities with industry-leading experts
- Competitive compensation and benefits package
Estimated Salary
Based on current market trends for Pharmacovigilance Operations professionals in Hyderabad:
Expected Salary Range: ₹8,00,000 – ₹15,00,000 per annum
Actual compensation may vary depending on qualifications, experience, and internal compensation policies.
How to Apply
