Global Pharmacovigilance Manager: Lead Safety Strategy

Amgen; United States; À distance; USD 116 000 - 157 000; Plein temps

Avantages offerts par ce poste

Retirement and Savings Plan

Stock-based long‑term incentives

Flexible work models

Comprehensive employee benefits

Résumé du poste

Amgen seeks a Global Pharmacovigilance Manager to lead product safety across the lifecycle, partnering with GSOs, Clinical Development, Regulatory Affairs, and cross‑functional teams to ensure safe and effective therapies for patients.

Responsibilities include signal detection, aggregate safety reporting, safety governance, and strategic safety input for protocols and clinical study reports within oncology, immunology, and rare diseases.

Qualifications

• Pharmacovigilance leadership and subject‑matter expertise required.
• Experience with biopharma/biotech safety data and signal management.
• Strong ability to interpret complex safety data for governance.
• Experience supporting regulatory submissions and inspections.

Responsabilités

• Lead product safety surveillance and signal management activities.
• Prepare and review aggregate safety reports (PBRERs/PSURs/DSURs).
• Provide strategic safety input into protocols and study reports.
• Present safety analyses to governance committees and leadership.

Connaissances

Pharmacovigilance leadership

Cross-functional collaboration

Scientific communication

Project management

Strategic safety

Formation

Doctorate degree

Master’s degree + 2 years PV

Bachelor’s degree + 4 years PV

Associate’s degree + 8 years PV

Outils

Argus Safety

Description du poste

Amgen seeks a Global Pharmacovigilance Manager to lead product safety across the lifecycle, partnering with GSOs, Clinical Development, Regulatory Affairs, and cross‑functional teams to ensure safe and effective therapies for patients.

Responsibilities include signal detection, aggregate safety reporting, safety governance, and strategic safety input for protocols and clinical study reports within oncology, immunology, and rare diseases.