Sr. Associate Pharmacovigilance Operations
Global biotechnology leader Amgen is hiring a Sr. Associate Pharmacovigilance Operations in Hyderabad. This opportunity is ideal for Pharmacovigilance professionals with experience in Aggregate Safety Reporting, DSUR, PSUR, PBRER, PADER, and Global Drug Safety Operations.
📋 Job Overview
| Particulars | Details |
|---|---|
| Position | Sr. Associate Pharmacovigilance Operations |
| Company | Amgen |
| Location | Hyderabad, Telangana |
| Experience | 3–8 Years |
| Department | Safety / Pharmacovigilance |
| Work Mode | On-Site |
| Job ID | R-246911 |
💼 Key Responsibilities
- Prepare and manage Periodic Aggregate Safety Reports (PASRs).
- Support DSUR, PSUR, PBRER, PADER, PAER, and SSUR preparation.
- Coordinate safety report timelines and stakeholder activities.
- Collect and review safety data contributions.
- Support aggregate report authoring and documentation.
- Conduct quality control review of safety reports.
- Maintain audit-ready safety documentation.
- Track compliance metrics, KPIs, and KCIs.
- Support literature management and process improvements.
- Ensure compliance with global pharmacovigilance regulations.
🎓 Eligibility Criteria
- B.Pharm
- M.Pharm
- B.Sc Life Sciences
- M.Sc Life Sciences
- Biotechnology
- Biochemistry
- Microbiology
- Clinical Research
- Related Healthcare Disciplines
- 3–8 Years Pharmacovigilance Experience
⭐ Required Skills
- Aggregate Safety Reporting
- DSUR Preparation
- PSUR & PBRER
- PADER / PAER
- Drug Safety Operations
- Medical Writing
- Regulatory Compliance
- Quality Review
- Stakeholder Management
- Risk Management
🌟 Why Join Amgen?
- Work with a global biotechnology leader.
- Exposure to international safety reporting.
- Career growth in aggregate reporting and risk management.
- Collaborate with global pharmacovigilance teams.
- Strong learning and development programs.
- Competitive compensation and benefits.
💰 Salary Information
Based on current industry benchmarks for Aggregate Safety Reporting and Pharmacovigilance Operations professionals in Hyderabad, the estimated salary range is:
₹8.0 LPA – ₹15.0 LPA
Actual compensation may vary depending on experience, aggregate report expertise, and interview performance.
📈 Career Path
- Drug Safety Associate
- Pharmacovigilance Associate
- Sr. Associate Pharmacovigilance Operations
- Aggregate Reporting Specialist
- Safety Scientist
- Senior Safety Scientist
- Pharmacovigilance Manager
- Global Safety Lead
📝 Resume Tips
- Highlight DSUR, PSUR, PBRER, and PADER experience.
- Mention aggregate safety reporting projects.
- Showcase medical writing and quality review activities.
- Include regulatory submission and compliance experience.
- Mention KPI, KCI, and safety metrics exposure.
- Use ATS-friendly Pharmacovigilance keywords.
🎯 Interview Preparation Tips
- Revise DSUR, PSUR, PBRER, and PADER concepts.
- Understand aggregate reporting workflows.
- Review global PV regulations and ICH guidelines.
- Practice benefit-risk evaluation concepts.
- Prepare examples of quality review activities.
- Understand safety metrics and compliance tracking.
- Research Amgen's pharmacovigilance operations.
❓ Common Interview Questions
- What is the purpose of a DSUR?
- Explain the difference between PSUR and PBRER.
- What information is included in aggregate safety reports?
- How do you manage report timelines and stakeholders?
- What is benefit-risk evaluation?
- How do you perform quality review of safety reports?
- What are KCI and KPI metrics in PV?
- How do you handle review comments from stakeholders?
- What challenges have you faced in aggregate reporting?
- Why do you want to join Amgen?
❓ Frequently Asked Questions (FAQ)
Q1. What experience is required?
3–8 years of Pharmacovigilance Operations or Aggregate Safety Reporting experience.
Q2. Which qualifications are eligible?
B.Pharm, M.Pharm, Life Sciences, Biotechnology, Biochemistry, Microbiology, Clinical Research, and related disciplines.
Q3. Is aggregate reporting experience mandatory?
Candidates with DSUR, PSUR, PBRER, or related report experience will have a strong advantage.
Q4. What is the work location?
Hyderabad, Telangana.
Q5. What domain does this role belong to?
Pharmacovigilance Operations and Aggregate Safety Reporting.
📝 How to Apply
- Update your resume with aggregate reporting experience.
- Highlight DSUR, PSUR, PBRER, and medical writing skills.
- Review the complete job description carefully.
- Apply through the official Amgen careers portal.
👉 Step-by-Step Guide: How to Apply for Healthcare & Pharma Jobs
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