Director Global Safety - Periodic Aggregate Safety Reports

About the role

Amgen is looking for a Director Global Safety to own the development of its Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs) in line with global regulatory requirements and Amgen's compliance policies. The role covers all aspects of PASRs and periodic reporting processes, schedules, outputs and metrics across the product life cycle, and leads a global team based in the US/EU and Amgen India.

Key responsibilities

• Lead the global PASR team so that all regulatory requirements for PASRs are met in production and submission.
• Develop and maintain the Global Periodic Reports Schedule, Standards and Procedures.
• Act as liaison between external vendors, Global Patient Safety and cross-functional teams (Regulatory Science, Global Clinical Development, Global Biostatistical Sciences, TS&BA, Centre for Observational Research).
• Carry out activities delegated by the QPPV as set out in the PV System Master File and stay ready for inspection.
• Serve as point of contact for Health Authority inspections and internal process audits within the remit of the role.
• Manage global staff in the functional area.

Required profile

• Degree: BS, RPH or RN HCP.
• Extensive drug safety experience with knowledge of the global aspects of pharmacovigilance.
• Strong knowledge of pharmacovigilance processes and global regulations, including periodic aggregate safety reporting.
• Understanding of emerging regulatory requirements and their implications for Amgen.
• Leadership experience managing a global team, with strong communication, planning and prioritisation skills.
• Excellent spoken and written English.

What we offer

• Opportunities to learn and move up and across the global organisation.
• A generous total rewards plan covering health, finance and wealth, work/life balance and career benefits.
• Flexible working: fully remote, or flexible from home with occasional office presence at the Cambridge or Uxbridge workspace.