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
Director Global Safety – Global Periodic Aggregate Safety Reports Director in London employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and growth of our employees. As an EU Regulatory Affairs Manager, you will be part of a diverse and inclusive team dedicated to serving patients, with ample opportunities for professional development and a generous Total Rewards Plan. With flexible working arrangements from our offices in Cambridge, Uxbridge, or Lisbon, you can enjoy a fulfilling career while maintaining a healthy work-life balance.
