Senior Global Pharmacovigilance Leader
Amgen SA
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Benefits offered by this job
Job summary
Amgen seeks a Global Pharmacovigilance Senior Manager to lead safety assessments and regulatory submissions in a fast-paced safety organization. You will collaborate with Therapeutic Safety Teams, manage aggregate reports, signal detection, and risk-management activities across multiple programs.
This role emphasizes leadership, integrity, and scientific judgment to protect patients. Amgen offers comprehensive benefits and opportunities for growth within an inclusive culture that values
Qualifications
- Doctorate or master or bachelor with PV experience across pharma.
- Expertise in safety signal detection and data interpretation.
- Experience with clinical trial safety and regulatory reporting.
- Strong written and verbal communication for cross-functional teams.
Responsibilities
- Directs planning, preparation, writing and review of portions of aggregate reports.
- Organizes liaison with affiliates and internal Amgen partners on products.
- Oversees safety in clinical trials, reviews protocols and analysis plans.
- Reviews AEs/SAEs and safety data listings across studies.
- Participates in study teams and risk management strategy development.
- Authors Safety Assessment Reports and regulatory responses with GSO.
Skills
Education
Tools
Job description
Amgen seeks a Global Pharmacovigilance Senior Manager to lead safety assessments and regulatory submissions in a fast-paced safety organization. You will collaborate with Therapeutic Safety Teams, manage aggregate reports, signal detection, and risk-management activities across multiple programs.
This role emphasizes leadership, integrity, and scientific judgment to protect patients. Amgen offers comprehensive benefits and opportunities for growth within an inclusive culture that values
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