Manager, Patient Safety Scientist
Core
Entry-level role supporting the Global Safety Physician and Senior/Principal PV Scientist in reviewing safety data, drafting safety documents, and managing risk plans for pharmaceutical products.
Role type
Entry-level Patient Safety Scientist (Manager title)
Builds
Safety documents, regulatory reports, and Risk Management Plans for designated products
Domain
Life Sciences / Pharmacovigilance
Required skills
Pharmacovigilance regulations, signal detection, database searches, regulatory document drafting, project management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Support proactive pharmacovigilance and risk management planning; Provide patient safety input to pivotal study documents; Run routine signal detection processes; Identify and retrieve relevant data for safety evaluation; Draft Reference Safety Information (RSI) and periodic regulatory documents; Provide input to global regulatory submissions
Seniority
Entry level