Global Pharmacovigilance Manager - Oncology

About the role

Amgen's Immuno-Oncology team manages a portfolio of investigational and marketed products and needs a Global Pharmacovigilance Manager to work closely with Global Safety Officers, Clinical Development and Regulatory Affairs. The role develops and executes product safety strategies across the product lifecycle, from early development through post-marketing, and leads signal detection, aggregation and risk management.

Key responsibilities

• Lead signal detection, validation, prioritization, evaluation and management, and perform scientific and medical evaluation of adverse events and emerging safety concerns
• Perform complex safety analyses, support benefit-risk evaluations, and recommend risk mitigation strategies with Global Safety Officers
• Lead or contribute to aggregate safety reports (PBRERs/PSURs, DSURs, Safety Assessment Reports) and regulatory safety responses
• Provide safety input to clinical protocols, statistical and safety analysis plans, investigator brochures and clinical study reports, and review safety data presentations
• Present safety analyses, signals and benefit-risk assessments to governance committees and influence strategic safety decisions
• Develop and maintain Risk Management Plans (RMPs) and risk minimization activities, and support regulatory submissions and inspections
• Improve PV processes and methods, and mentor junior pharmacovigilance scientists

Required profile

• Doctorate, or Master's degree plus 2 years of industry PV experience, or Bachelor's degree plus 4 years, or Associate's degree plus 8 years, or high school diploma plus 10 years of industry PV experience
• Preferred: advanced scientific or healthcare degree (PharmD, PhD, RN, NP, PA, MD or equivalent)
• Preferred: 5+ years of PV or drug safety experience in biotechnology, pharmaceutical or CRO settings

Required skills

• Signal detection, evaluation, analysis and management
• Authoring and reviewing aggregate safety reports (PBRERs, PSURs, DSURs)
• Knowledge of FDA, EMA, ICH and global PV regulations
• Experience with Argus Safety and/or other global safety databases and signal management tools