Director of Claims Operations overseeing Accident Benefits to drive growth and customer service at Intact. Collaborating with executives and managing team resources for effective delivery.
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
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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