Global Pharmacovigilance (PV) Scientist, Manager- Oncology
Core
Lead product safety surveillance, signal management, and aggregate safety reporting for oncology and immunology products across the product lifecycle.
Role type
Manager-level pharmacovigilance scientist (oncology)
Builds
Safety strategies, aggregate safety reports (PBRERs/PSURs/DSURs), risk management plans, and regulatory safety submissions
Domain
Biopharmaceuticals / Oncology / Pharmacovigilance
Required skills
Signal detection and management, aggregate safety report authoring, benefit-risk assessment, risk minimization strategy development, regulatory compliance (GVP/ICH), cross-functional safety leadership
Preferred skills
Advanced scientific/healthcare degree (PharmD, PhD, MD), experience with Argus Safety or similar databases, literature surveillance, clinical protocol safety input
Technologies
Argus Safety, global safety databases
Responsibilities
Lead signal detection, validation, and evaluation; author and review aggregate safety reports; support clinical development safety plans; develop risk management plans; ensure regulatory compliance and inspection readiness; mentor junior scientists (via careerplan.io/jobs/R-256870-global-pharmacovigilance-pv-scientist-manager-oncology-at-amgen)
Seniority
Manager, hands-on IC with team leadership