Patient Safety PVSci Manager
Core
Leads pharmacovigilance science activities including cross-functional safety data monitoring, aggregate reporting to regulatory agencies, and signal/risk management for assigned products.
Role type
Senior IC pharmacovigilance science manager
Builds
Aggregate safety reports, risk management plans, and regulatory submissions
Domain
Biotechnology / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance, data analysis, medical/scientific writing, project management, regulatory reporting, signal detection, risk management
Preferred skills
Advanced healthcare degree, aggregate/periodic safety report preparation
Technologies
Electronic safety databases, regulatory submission systems
Responsibilities
Coordinate review of emerging safety data, prepare aggregate safety report content, conduct signal detection and risk management assessments, manage timelines for PVSci deliverables, develop materials for safety forums, support epidemiology-led study documentation, liaise with Regulatory Affairs for report submissions
Seniority
Senior, hands-on IC
