Director Global Safety – Global Periodic Aggregate Safety Reports Director
Amgen · Cambridge, UK +2 more
SafetyFull-timeCompany career page
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Role summary
Director role overseeing global periodic aggregate safety reports (PASRs) strategy and operations across product lifecycles. Leads a distributed team ensuring pharmacovigilance compliance with regulatory requirements and Amgen standards.
What they're looking for
- Bachelor's degree (BS, RPH, RN, or HCP qualification)
- Extensive drug safety experience with demonstrated global pharmacovigilance knowledge
- Strong understanding of pharmacovigilance processes and global periodic reporting regulations
- Subject matter expertise and technical excellence in the field
- Proven global team leadership with cross-functional collaboration experience
- Strong organizational, planning, and priority management skills
- Fluent English communication, both written and oral
What you'll be doing
- Lead global PASR team to ensure all regulatory requirements are met for report production and submission
- Develop and maintain global periodic reports schedules, standards, and procedures
- Serve as liaison between external vendors, patient safety, and cross-functional teams on PASR creation
- Act as primary contact for health authority inspections and internal audits within role scope
- Manage global staff within the functional area
Privacy & handoff
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