Senior Manager, Safety Scientist
Core
Senior Manager leading global patient safety risk evaluation, regulatory reporting, and safety strategy execution across the product lifecycle.
Role type
Senior Manager, Safety Scientist (Pharmacovigilance)
Builds
Aggregate safety reports (PSUR, PBRER), risk management plans, and regulatory submissions for assigned therapeutic assets.
Domain
Life Sciences / Pharmacovigilance / Regulatory Affairs
Required skills
Global pharmacovigilance regulations, safety data analysis, clinical document authoring, risk management strategy, regulatory filing support, team leadership, signal analysis, project management
Preferred skills
Advanced degree (PharmD/NP/PhD), aggregate safety report preparation, clinical development experience, clinical database expertise, MedDRA coding, data visualization (Power BI, Spotfire)
Technologies
eCTD, MedDRA, Power BI, Spotfire
Responsibilities
Evaluate and manage safety risks throughout product lifecycle; author/review clinical safety documents (protocols, IB, CSR); coordinate aggregate safety reports for regulatory submission; oversee safety strategy and surveillance teams; lead signal analysis and communication; manage health authority queries; develop risk management strategies; train junior safety scientists.
Seniority
Senior Manager, hands-on IC with leadership responsibilities