Senior Manager, Patient Safety Scientist
Core
Lead pharmacovigilance safety science, signal detection, and risk management strategies to ensure the safe use of medicines across the product lifecycle.
Role type
Senior Manager, Patient Safety Scientist (Pharmacovigilance)
Builds
Global safety data packages, regulatory submissions, and risk management plans for pharmaceutical products.
Domain
Pharmaceutical industry, Pharmacovigilance, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global pharmacovigilance regulations, quantitative signal detection, aggregate safety document preparation, clinical development safety sections, risk management plan development, AI and digital safety tools
Preferred skills
None stated
Technologies
AI, automation, digital platforms
Responsibilities
Lead quantitative signal detection and author comprehensive signal reports; Prepare and contribute to aggregate safety documents (DSURs, PBRERs, PADERs); Author safety sections of regulatory submissions (MAAs, ISS, SCS, clinical overviews, product labelling); Develop and maintain global and EU Risk Management Plans and Post-Authorisation Safety Studies; Lead safety data review meetings and drive risk management strategies.
Seniority
Senior Manager, hands-on IC with strategic oversight
