Sr. Associate Pharmacovigilance Operations

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 :

Skills Required

Pharmacovigilance, Regulatory Compliance, Data Analysis, Risk Management, Clinical Trials