Director Global Safety- Global Periodic Aggregate Safety Reports
$191.07kAmgen Inc
Director of Global Safety role overseeing pharmacovigilance operations and periodic aggregate safety reports (PASRs) across Amgen's product portfolio. Lead a global team ensuring compliance with regulatory requirements and internal standards throughout product lifecycles.
Responsibilities
- Lead global PASR team to ensure regulatory compliance in report production and submission
- Develop and maintain global periodic reports schedule, standards, and procedures
- Serve as liaison between external vendors, patient safety, regulatory, and clinical teams
- Manage staff in functional area and support audit and inspection readiness
- Act as point of contact for health authority inspections and internal process audits
Requirements
- Doctorate degree and 4 years global safety experience, OR Master's and 8 years, OR Bachelor's and 10 years
- Minimum 4 years managing people or leading teams and projects
- Knowledge of pharmacovigilance operations and PASR regulatory requirements
- Experience liaising with health authorities and regulatory bodies
- Leadership experience managing cross-functional global teams
Compensation: $191,067 base
Vacancy posted 2 days ago
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