Senior Manager – Global Pharmacovigilance & Safety

Amgen; Washington (District of Columbia); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Retirement savings plan

Job summary

Amgen is seeking a Global Pharmacovigilance Senior Manager to lead safety assessments across therapeutic areas. You will guide aggregate safety reporting, collaborate with affiliates, and mentor staff to ensure compliant pharmacovigilance programs.

You will oversee risk management activities, support regulatory filings, and drive inspection readiness with the GSO. A Doctorate or relevant advanced degree with PV experience is preferred, and Amgen values diversity.

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 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 and support on study protocols, statistical analysis plans and other clinical study-related documents
• Review of AEs/SAEs from clinical trials as needed
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Participate in development of safety-related data collection forms for clinical studies
• Participate in study team meetings as requested or needed
• Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
• Documents work as required in the safety information management system
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
• Assist GSO in the development of risk management strategy and activities:
• Provides contents for risk management plans
• Develop or update strategy and content for regional risk management plans
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities, Provide safety contents for filings
• Inspection Readiness
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Skills

PV experience

Signal detection

Literature surveillance

Risk management

Clinical safety

Regulatory filings

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 across therapeutic areas. You will guide aggregate safety reporting, collaborate with affiliates, and mentor staff to ensure compliant pharmacovigilance programs.

You will oversee risk management activities, support regulatory filings, and drive inspection readiness with the GSO. A Doctorate or relevant advanced degree with PV experience is preferred, and Amgen values diversity.