Global PV Senior Manager: Safety Strategy & Signals

Amgen; Washington (District of Columbia); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision benefits

Life and disability insurance

Flexible spending accounts

Discretionary bonus

Job summary

Amgen is seeking a Global Pharmacovigilance Senior Manager to oversee safety data assessment, reporting, and regulatory interactions across therapeutic areas. You will lead cross-functional teams and liaise with affiliates to ensure high-quality safety deliverables.

The role emphasizes inspection readiness, risk management strategies, and collaboration with GSO to support regulatory filings and pharmacovigilance operations.

Qualifications

• Doctorate or advanced degree with PV experience.
• Strong knowledge of safety data analysis and regulatory writing.
• Experience in coordinating cross-functional safety activities.

Responsibilities

• Directs planning, writing and review of safety reports.
• Oversees safety data management and signal detection activities.
• Collaborates with affiliates and internal partners on safety issues.
• Supports risk management and regulatory submissions.
• Ensures inspection readiness and audit responses.

Skills

PV leadership

Safety data analysis

Cross-functional collaboration

Regulatory writing

Clinical safety

Education

Pharmacovigilance Doctorate

PV Masters

Life sciences Bachelor

HS diploma

Job description

Amgen is seeking a Global Pharmacovigilance Senior Manager to oversee safety data assessment, reporting, and regulatory interactions across therapeutic areas. You will lead cross-functional teams and liaise with affiliates to ensure high-quality safety deliverables.

The role emphasizes inspection readiness, risk management strategies, and collaboration with GSO to support regulatory filings and pharmacovigilance operations.