Senior Global Pharmacovigilance Leader

Amgen SA; United States; Hybrid; USD 150,000 - 230,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Life and disability insurance

Flexible work models

Annual bonus program

Job summary

Amgen is seeking a Global Pharmacovigilance Senior Manager to lead safety activities across therapeutic areas and collaborate with Therapeutic Safety Teams on safety assessment for medical operations.

The role involves directing reports, supporting regulatory interactions, and guiding staff on safety in clinical trials, with a focus on signal detection, risk management, and regulatory readiness. Amgen values collaboration and scientific excellence.

Qualifications

• Doctorate or Master’s/Bachelor’s with multi-year pharmacovigilance experience in the industry.
• Experience with safety in clinical trials and regulatory submissions.
• Strong analytical and scientific judgment in drug safety.

Responsibilities

• Directs aggregate report planning, preparation, writing and review.
• Oversees liaison with affiliates and internal Amgen partners on products.
• Provides guidance on safety in clinical trials and study documents.
• Reviews AEs/SAEs and safety data presentations.
• Develops safety-related data collection forms for studies.
• Participates in safety data risk management and decision making.
• Leads data analysis for safety signals and writes conclusions.
• Prepares safety assessment reports with GSO collaboration.
• Supports readiness for inspections and regulatory inquiries.

Skills

Pharmacovigilance

Leadership

Safety reporting

Clinical trial knowledge

Data analysis

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 activities across therapeutic areas and collaborate with Therapeutic Safety Teams on safety assessment for medical operations.

The role involves directing reports, supporting regulatory interactions, and guiding staff on safety in clinical trials, with a focus on signal detection, risk management, and regulatory readiness. Amgen values collaboration and scientific excellence.