Manager, Patient Safety Scientist
Core
Entry-level scientist supporting Global Safety Physicians and Senior PV Scientists in reviewing safety data, drafting regulatory reports, and managing risk plans for pharmaceutical products.
Role type
Entry-level Patient Safety Scientist (Pharmacovigilance)
Builds
Safety documents, regulatory reports (PBRERs, PSURs, DSURs), Risk Management Plans, and input for global regulatory submissions.
Domain
Life Sciences / Pharmacovigilance / Drug Development
Required skills
Pharmacovigilance regulations knowledge, signal detection, database searching, regulatory document drafting, project management for safety aspects, stakeholder coordination
Preferred skills
Advanced Patient Safety knowledge, Clinical/Drug Development experience
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; Raise concerns/issues to senior staff
Seniority
Entry-level, hands-on IC