Director Global Safety – Global Periodic Aggregate Safety Reports Director

Overview

In this role you will lead the global Pharmacovigilance Operations for PASR development and submission, ensuring regulatory compliance and alignment with Amgen standards. You will manage a cross‑regional team and coordinate with external vendors and cross‑functional partners to maintain a robust PASR program. You will drive inspection readiness and act as a liaison with health authorities and internal stakeholders. This position offers a strategic leadership opportunity to shape global safety reporting and lifecycle oversight for Amgen products. Join a mission‑driven team that collaborates across borders to deliver safer, better medicines at scale.

Pay / Benefits

• Total Rewards Plan
• health, finance and wealth benefits
• work/life balance
• opportunity to work remotely
• career growth and mobility
• inclusive, diverse culture

Responsibilities

• Provide global leadership for the PASR team to ensure regulatory requirements are met in production and submission of all reports
• Develop and maintain the Global Periodic Reports Schedule, Standards and Procedures
• Coordinate with external vendors, Global Patient Safety, Regulatory Science, Global Clinical Development, Global Biostatistical Sciences, TS&BA, and Centre for Observational Research in PASR creation
• Maintain PV System Master File and ensure inspection readiness as delegated by the QPPV
• Serve as the point of contact for Health Authority inspections and internal process audits
• Manage global staff in the functional area

Key requirements

• BS
• Extensive experience in Drug Safety with global pharmacovigilance knowledge
• Strong knowledge of processes and regulations for pharmacovigilance and PASRs
• Understanding of emerging regulatory requirements and implications for Amgen
• Subject matter expertise and technical excellence in PV
• Experience working on cross‑functional teams
• Strong leadership, networking and influencing skills with experience managing stakeholder conflicts
• Proven ability to execute goals and processes across a global team
• Ability to plan and prioritize workload; manage competing priorities and timelines
• Excellent oral and written English

• leadership
• cross‑functional collaboration
• influence and negotiation
• pharmacovigilance
• global regulatory requirements for PASRs
• PV System Master File

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