Senior Global Pharmacovigilance Leader

Amgen SA; United States; Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Retirement and Savings Plan

Life and disability insurance

Medical/dental/vision coverage

Job summary

Amgen is seeking a Global Pharmacovigilance Senior Manager to lead safety assessment activities with Therapeutic Safety Teams for medical/scientific operations. You will direct safety data collection, analysis and reporting across trials.

The role requires advanced degrees and multiple years of industry pharmacovigilance experience, plus people management. Amgen offers a comprehensive benefits package, flexible work models, and opportunities to advance your career.

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
• Bachelor’s in life science and Master’s and 6 years of related experience
• 2 years of managerial experience directly managing people or projects
• Clinical or medical research experience
• 6 years of experience in the biotech/pharmaceutical setting

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

Education

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

Job description

Amgen is seeking a Global Pharmacovigilance Senior Manager to lead safety assessment activities with Therapeutic Safety Teams for medical/scientific operations. You will direct safety data collection, analysis and reporting across trials.

The role requires advanced degrees and multiple years of industry pharmacovigilance experience, plus people management. Amgen offers a comprehensive benefits package, flexible work models, and opportunities to advance your career.