Global Pharmacovigilance Lead: Safety Strategy & Oversight

Regulatory Jobs; United States; Remote; USD 141,000 - 190,000; Full time

Job summary

Amgen is seeking a Global Pharmacovigilance Senior Manager to lead safety assessments, risk management strategy, and regulatory communications within Therapeutic Safety Teams. You will oversee aggregate reports, signal detection, and safety data reviews across clinical trials.

The role requires advanced PV expertise and leadership, with a focus on collaboration across functions to protect patient safety and drive continuous improvement.

Qualifications

• Doctorate degree with 2 years of pharmacovigilance experience.
• Master’s degree with 4 years of industry pharmacovigilance experience.
• Bachelor's degree with 6 years of industry pharmacovigilance experience.
• Associate’s degree with 10 years of industry pharmacovigilance experience.
• High school diploma/GED and 12 years of industry pharmacovigilance experience.
• BS in Life Science with 3 years drug safety experience, preferably industry pharmacovigilance.
• Experience in Signal detection, evaluation and management.
• Experience of Literature Surveillance: source document review knowledge and skills.
• Experience in aggregate data analysis, interpretation and synthesis.
• Good clinical and scientific judgment.
• Clinical and/or medical research experience.
• Understanding of methods of qualitative and quantitative safety data analysis.

Responsibilities

• Directs the planning, preparation, writing and review of portions of aggregate reports.
• Organize and direct liaison for activities with affiliates and internal Amgen partner regarding products.
• Supports and provides oversight to staff with regards to safety in clinical trials.
• Review of AEs/SAEs from clinical trials as needed.
• Review safety data tables, figures and listings for clinical studies.
• Assist in development of risk management plans and safety data collection forms.

Skills

Leadership

Pharmacovigilance

Safety data analysis

Cross-functional collaboration

Regulatory knowledge

Signal detection

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate’s degree

High school diploma

Job description

Amgen is seeking a Global Pharmacovigilance Senior Manager to lead safety assessments, risk management strategy, and regulatory communications within Therapeutic Safety Teams. You will oversee aggregate reports, signal detection, and safety data reviews across clinical trials.

The role requires advanced PV expertise and leadership, with a focus on collaboration across functions to protect patient safety and drive continuous improvement.