Sr. Associate Pharmacovigilance Operations
Amgen(8 months ago)
About this role
The role supports authoring, compilation and peer review of Amgen’s Periodic Aggregate Safety Reports (PASRs) and certain country-specific safety reports in compliance with global regulatory requirements. The position manages the end-to-end report writing and documentation process, coordinates cross-functional contributors, and ensures timelines and quality standards are met. It also helps maintain regulatory knowledge, metrics, and archival records for safety report submissions.
Required Skills
- Report Authoring
- Report Compilation
- Peer Review
- Stakeholder Coordination
- Timeline Management
- Regulatory Knowledge
- Documentation
- Quality Control
- Metrics Reporting
- Literature Management
Qualifications
- Bachelor's Degree in Life Sciences
- Master's Degree in Life Sciences
- Bachelor's Degree in Pharmacy
- Master's Degree in Pharmacy
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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