Global Pharmacovigilance Safety Lead

Amgen Inc.; USA; Hybrid; USD 141.000 - 190.000; Vollzeit

Benefits dieser Stelle

Retirement and Savings Plan with big公司

Sales‑based incentive plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Zusammenfassung

Amgen Inc. in the United States is seeking a Global Pharmacovigilance Senior Manager to lead safety activities across therapeutic areas.

You will oversee safety assessments, aggregate reports, and cross‑functional collaborations with affiliates and internal partners to ensure rigorous risk management and regulatory readiness. The role emphasizes leadership of safety teams, signal evaluation, and preparation of Safety Assessment Reports, with flexible work models where possible and a competitive,

Qualifikationen

• Doctorate degree and 2 years of industry pharmacovigilance experience.
• Master’s degree and 4 years of industry pharmacovigilance experience.
• Bachelor's degree and 6 years of industry pharmacovigilance experience.
• Associate’s degree and 10 years of industry pharmacovigilance experience.
• High school diploma/GED and 12 years of industry pharmacovigilance experience.

Aufgaben

• Directs the planning, preparation, writing and review of portions of aggregate reports.
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products.
• Supports and provides oversight to staff with regards to safety in clinical trials to review and provide input on study protocols and related documents.
• Review of AEs/SAEs from clinical trials as needed.
• Review standard design of safety data tables, figures, and listings.

Kenntnisse

Pharmacovigilance

Regulatory knowledge

Leadership

Risk management

Cross-functional collaboration

Ausbildung

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

PV System

Jobbeschreibung

Amgen Inc. in the United States is seeking a Global Pharmacovigilance Senior Manager to lead safety activities across therapeutic areas.

You will oversee safety assessments, aggregate reports, and cross‑functional collaborations with affiliates and internal partners to ensure rigorous risk management and regulatory readiness. The role emphasizes leadership of safety teams, signal evaluation, and preparation of Safety Assessment Reports, with flexible work models where possible and a competitive,