Director Global Safety- Global Periodic Aggregate Safety Reports
About The Position
The Director Global Safety is accountable for developing Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs), in compliance with global regulatory requirements and Amgen policies and standards. The role oversees PASRs and periodic reporting processes, schedules, outputs, and metrics throughout each product’s life cycle, and leads a global team with members in the US, EU, and Amgen India. The position participates in cross-functional activities to promote compliant and consistent PASR preparation for all Amgen products throughout their life cycles. It also undertakes activities delegated by the QPPV as detailed in the PV System Master File, maintains inspection readiness, and serves as a point of contact for Health Authority inspections and internal process audits within the role’s remit.
Requirements
- Doctorate degree and 4 years of Global Safety experience; or master’s degree and 8 years of Global Safety experience; or bachelor’s degree and 10 years of Global Safety experience.
- At least 4 years of experience directly managing people and/or leading teams, projects, or programs, or directing resource allocation. This experience may run concurrently with the required technical experience.
Responsibilities
- Provide global leadership for the PASR team to ensure regulatory requirements are met in the production and submission of reports.
- Develop and maintain the Global Periodic Reports Schedule, standards, and procedures.
- Liaise among external vendors, Global Patient Safety, and cross-functional teams—including Regulatory Science, Global Clinical Development, Global Biostatistical Sciences, TS&BA, and the Centre for Observational Research—to create PASRs.
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain inspection readiness.
- Serve as the point of contact for Health Authority inspections and internal process audits within the role’s remit.
- Manage global staff in the functional area.
- Participate in cross-functional activities to promote compliance and consistency in PASR preparation across Amgen products throughout their life cycles.
Benefits
- Health and welfare plans for staff and eligible dependents
- Retirement and Savings Plan with company contributions
- Medical, dental, and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program (or a sales-based incentive plan for field sales representatives)
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Director
