Director Pharmacovigilance Operations
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high‑level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life‑interrupting illnesses.
What you will do
In this vital role you will 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. You will ensure compliance with global pharmacovigilance (PV) regulations, manage vendor oversight, and drive continuous process improvement across safety operations.
Key Responsibilities
* 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.
What we expect of you
* 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.
What you can expect of us
* 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.
Location
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next‑generation workspace.
Apply Now
for a career that defies imagination
What we do is hard. It should be. We are working with each other against the challenges of today for the promise of tomorrow. Lead the way.
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