Hybrid Director, Pharmacovigilance Operations

at Amgen

• Job title: Director, Pharmacovigilance Operations
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Uxbridge, United Kingdom

About the role

• Director of Pharmacovigilance Operations at Amgen acting as primary contact for safety reporting and managing compliance. Leading teams on adverse event management and process improvements.

Responsibilities

• Act as the US/EU Local Safety Officer and primary FDA/EMA contact for safety reporting, overseeing all adverse event intake, case processing, and submissions for the Rare Disease portfolio.
• Ensure compliance with global pharmacovigilance (PV) regulations, manage vendor oversight, and drive continuous process improvement across safety operations.
• Oversee adverse event case intake, processing, and reporting to FDA/EMA, business partners, license partners and vendors.
• Serve as Business Process Owner for adverse event (AE) Intake, ensuring compliance, training, and process control.
• Ensure vendor adherence to approved procedures and performance standards; monitor quality and compliance metrics.
• Act as liaison between Global Patient Safety, clinical teams, and business partners to ensure complete and accurate AE data capture.
• Support inspection readiness, audits, and CAPA follow-up; serve as point of contact for regulatory inspections.
• Lead electronic serious adverse events (eSAE) governance and contribute to process improvement and implementation of new safety systems and standards.
• Develop and maintain SOPs, training materials, and safety documentation in compliance with global PV requirements.
• Foster cross-functional communication and collaboration across Global Safety, Clinical Operations, and external partners.

Requirements

• Degree educated.
• Demonstrated experience in pharmacovigilance drug safety/life sciences industry.
• Proven record of leading and managing teams, ideally with global or cross-regional scope.
• Strong decision-making and strategic capabilities, with experience building and sustaining effective cross-functional partnerships and communication channels.

Benefits

• Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits