Sr. Associate Pharamocovigilance Operations

About the Role This position focuses on the authoring, compilation and peer review of Amgen’s Periodic Aggregate Safety Reports (PASRs) and related safety submissions, ensuring alignment with global regulatory requirements and timelines. The role supports end-to-end writing and documentation processes and collaborates with cross-functional teams to deliver accurate safety reporting. What You'll Do

• Compile and author PASRs including DSUR, PBRER/PSUR, SSUR, PADER/PAER, Device PSUR, and country-specific reports (e.g., Korea PSUR, Brazil PSUR, Colombia Clinical Research Annual Safety Report). Maintain compliance with regulatory requirements.
• Coordinate and schedule meetings with cross-functional stakeholders to enable collaboration and alignment.
• Drive report timelines and escalate risks or delays to team leads or management.
• Collect PASR contributions from cross-functional stakeholders and external partners, and assemble into PASR templates.
• Author safety content for PASRs in collaboration with Therapeutic Area Safety scientists.
• Conduct peer QC of safety sections, coordinate Amgen reviews and resolve comments, and initiate approval workflows.
• Maintain and archive accurate records and documentation throughout the report process.
• Review and approve published report versions (e.g., blinded, unblinded, EU FDA, Rest of World).
• Manage report distribution to CROs and Business Partners (BPs).
• Ensure adherence to established timelines, regulatory guidelines, and applicable standards and processes.
• Peer review/quality review of all PASRs within established timelines using appropriate checklists.
• Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards.
• Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
• Literature Management Process: May assist with literature management activities as required. What We're Looking For
• Experience in pharmacovigilance and safety reporting with direct involvement in PASRs and related safety submissions (e.g., DSUR, PBRER/PSUR, SSUR, PADER/PAER).
• Proven ability to coordinate cross-functional teams, manage timelines, and escalate risks.
• Strong technical writing, editing and peer-review skills with attention to accuracy and regulatory expectations.
• Knowledge of regulatory guidelines and industry standards for PASRs; familiarity with PASR templates and distribution to CROs/BPs.
• Ability to maintain documentation and records, and to adapt to evolving regulatory expectations.
• Proactive learner with capacity to stay current on regulatory guidelines and industry advances. Nice to Have
• Experience with country-specific safety reporting requirements (e.g., Korea, Brazil, Colombia) is a plus. Compensation & Benefits
• Not disclosed in the posting.