Amgen is a global biotechnology leader committed to serving patients with serious illnesses. Since 1980, Amgen has pioneered innovative treatments in Oncology, Inflammation, General Medicine, and Rare Diseases, impacting millions of lives worldwide.
With a collaborative, science-driven culture, Amgen fosters innovation and excellence. If you’re passionate about making a difference in healthcare, join Amgen to transform patient lives while advancing your career.
Open Positions at Amgen Hyderabad
1. Periodic Report Specialist
Job ID: R-216828
Key Responsibilities:
- Author and compile Periodic Aggregate Safety Reports (PASRs) like DSUR, PBRER/PSUR, PADER, and country-specific reports (e.g., Korea PSUR, Brazil PSUR).
- Coordinate cross-functional meetings to ensure timely report submissions.
- Ensure compliance with global pharmacovigilance regulations.
- Conduct peer QC reviews and manage report approvals.
- Maintain documentation and support inspection readiness.
Qualifications:
- Master’s degree + 1-3 years / Bachelor’s + 3-5 years / Diploma + 7-9 years in pharma/biotech/regulatory field.
- Experience in safety report writing (DSUR, PBRER, PSUR).
- Strong scientific writing, project management, and regulatory compliance skills.
2. Periodic Report QC Reviewer
Job ID: R-216803
Key Responsibilities:
- Perform quality control reviews of PASRs (PBRER, DSUR, PADER).
- Ensure accuracy, consistency, and regulatory compliance.
- Track QC metrics and support continuous improvement.
- Collaborate with report specialists to resolve discrepancies.
Qualifications:
- Master’s + 1-3 years / Bachelor’s + 3-5 years / Diploma + 7-9 years in pharma/biotech.
- Strong attention to detail and knowledge of pharmacovigilance regulations.
- Experience in medical writing/QC for safety reports.
3. Periodic Report Manager
Job ID: R-216826
Key Responsibilities:
- Lead a team of Periodic Report Specialists in Hyderabad.
- Oversee end-to-end PASR production, ensuring compliance.
- Act as primary contact for regulatory challenges and solutions.
- Drive timelines, metrics, and inspection readiness.
Qualifications:
- Master’s + 4-6 years / Bachelor’s + 6-8 years / Diploma + 10-12 years in pharma/biotech.
- 5+ years in safety report writing (DSUR, PBRER, PSUR).
- Leadership experience in pharmacovigilance operations.
Why Join Amgen?
✅ Innovative Culture – Work on cutting-edge biotech advancements.
✅ Patient Impact – Contribute to life-saving therapies.
✅ Career Growth – Competitive benefits & professional development.
✅ Global Compliance – Be part of a best-in-class pharmacovigilance team.
How to Apply
Application Link For Periodic Report Specialist
