Senior Manager, Global Pharmacovigilance Scientist

About the role

Amgen is hiring a Senior Manager, Global Pharmacovigilance (PV) Scientist to work with its Therapeutic Safety Teams on safety assessment activities for medical and scientific operations. The role covers aggregate reporting, signal detection, risk management and regulatory support, and is open to candidates with a doctorate, master's, bachelor's, associate's degree or high school diploma, with corresponding years of industry experience.

Key responsibilities

• Direct the planning, preparation, writing and review of portions of aggregate reports, and liaise with affiliates and internal partners on product matters
• Oversee safety in clinical trials: review study protocols, statistical analysis plans and other documents, review AEs/SAEs, and review standard design of tables, figures and listings for safety data
• Help develop safety data collection forms and take part in study team meetings
• Perform data analysis to evaluate safety signals, document work in the safety information management system, and author safety assessment reports and regulatory responses with the GSOS
• Search and review adverse event data, literature and other safety data for signal detection, and present the Global Safety Team's recommendations to the cross-functional decision-making body
• Assist the GSO in risk management: contribute to risk management plans, develop regional plans, track risk minimization activities, and respond to regulatory inquiries
• Support new drug applications and other regulatory filings, and prepare inspection readiness activities as delegated by the QPPV, acting as the point of contact for Health Authority inspections and internal audits

Required profile

• Basic qualification: doctorate with 2 years of industry PV experience, or master's with 4 years, or bachelor's with 6 years, or associate's with 10 years, or high school diploma/GED with 12 years of industry PV experience
• Preferred: BS in Life Sciences with 3 years of drug safety experience, preferably in industry PV
• Preferred: experience in signal detection, literature surveillance, aggregate data analysis, and good clinical and scientific judgment

Required skills

• Knowledge of qualitative and quantitative safety data analysis methods
• Literature surveillance and aggregate data analysis

What we offer

• Annual salary range of $140,799 to $190,492 in the U.S. (excluding Puerto Rico)
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and flexible work models where possible