Global PV Strategy Lead - Senior Manager

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 141,000 - 190,000; Full time

Job summary

Amgen Inc. in Thousand Oaks, CA, seeks a Global Pharmacovigilance Senior Manager to lead safety assessment activities and coordinate with Therapeutic Safety Teams across clinical development and post-marketing.

You will oversee aggregate reports, risk management planning, signal detection, and regulatory interactions, ensuring inspection readiness and high standards of data quality across global safety operations.

Qualifications

• 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

Responsibilities

• Directs planning, preparation, and review of portions of aggregate reports
• Oversees liaison with affiliates and internal Amgen partners on products
• Provides oversight for safety in clinical trials and study documentation
• Reviews AEs/SAEs and safety data listings from trials
• Participates in development of safety data collection forms
• Performs signal detection and writes up analysis results

Skills

Safety data analysis

Regulatory compliance

Cross-functional collaboration

Risk management

Education

Doctorate degree

Master’s degree

Bachelor's degree

Associate’s degree

High school diploma

Job description

Amgen Inc. in Thousand Oaks, CA, seeks a Global Pharmacovigilance Senior Manager to lead safety assessment activities and coordinate with Therapeutic Safety Teams across clinical development and post-marketing.

You will oversee aggregate reports, risk management planning, signal detection, and regulatory interactions, ensuring inspection readiness and high standards of data quality across global safety operations.