Periodic Report Specialist
AmgenHyderabad, Telangana, India
Posted September 10, 2025
Full Time
About the Company
Amgen is a leading biotechnology company
Job Description
Periodic Report Specialist plays a role in authoring, compilation, and peer review of Amgen's Periodic Aggregate Safety Reports (PASR).
Requirements
- Compilation and authoring of PASRs
- Coordinate and schedule meetings with cross-functional stakeholders
- Drive report timelines and escalate risks or delays
- Collaborate with cross-functional stakeholders and external business partners
- Author safety content for all PASRs
- Conduct peer QC of safety authored sections
- Maintain and archive accurate records and documentation
- Review and approve published report versions
- Manage report distribution to CROs and BPs
- Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes
- Peer review/quality review of all PASRs
- Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards
- Generate PASR metrics, including KCIs and KPIs