Key Responsibilities:
- Compile and author Periodic Aggregate Safety Reports (PASRs) ensuring accuracy and compliance.
- Coordinate and schedule meetings with cross-functional stakeholders to ensure effective collaboration and alignment.
- Drive report timelines, monitor progress, and escalate risks or delays to team leads or management.
- Collaborate with cross-functional teams and external partners to gather PASR contributions and consolidate into templates.
- Author safety content in partnership with Therapeutic Area Safety scientists.
- Conduct peer quality control reviews of authored safety sections, coordinate Amgen internal reviews, resolve comments, and initiate approval workflows.
- Maintain and archive accurate documentation throughout the report lifecycle.
- Review and approve final published report versions (including blinded, unblinded, EU FDA, Rest of World versions).
- Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs).
- Ensure adherence to regulatory guidelines, company standards, timelines, and style guidelines.
- Perform peer and quality reviews of all PASRs within timelines using established checklists and processes.
- Maintain and update knowledge of regulatory guidelines, technological advancements, and industry best practices.
- Generate and report PASR metrics including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
- Assist with Literature Management activities as needed.
Basic Qualifications and Experience:
- Master's degree or Bachelor's degree with 5 years of relevant experience.
