Global Pharmacovigilance Leader – Oncology

Amgen SA; United States, Northern America, Americas; Hybrid; USD 130,000 - 170,000; Full time

Job summary

Amgen is seeking a Global Pharmacovigilance Manager to lead safety surveillance, signal detection, and evaluation across datasets. You will drive aggregate reporting, regulatory submissions, and cross-functional collaboration to ensure product safety throughout the lifecycle.

The role emphasizes strategic safety input into clinical development, governance storytelling, and risk-management planning, in a dynamic, globally focused team environment.

Qualifications

• Doctorate degree or equivalent pharmacovigilance experience.
• 5+ years pharmacovigilance in biotech/pharma or CRO environments.
• Experience in signal detection, evaluation, and management.

Responsibilities

• Lead signal detection, validation, prioritization, evaluation and management across data sources.
• Prepare and review aggregate safety reports (PBRERs, PSURs, DSURs) and regulatory safety responses.
• Provide strategic safety input into protocols, SSPS, and study reports.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and Epidemiology.

Skills

Signal detection

Signal management

Safety surveillance

Data analysis

Cross-functional leadership

Scientific leadership

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Argus Safety

Job description

Amgen is seeking a Global Pharmacovigilance Manager to lead safety surveillance, signal detection, and evaluation across datasets. You will drive aggregate reporting, regulatory submissions, and cross-functional collaboration to ensure product safety throughout the lifecycle.

The role emphasizes strategic safety input into clinical development, governance storytelling, and risk-management planning, in a dynamic, globally focused team environment.