Associate Director, PV Scientist
Core
Lead Pharmacovigilance (PV) scientist providing strategic direction and scientific oversight for safety surveillance and aggregate reporting of investigational and marketed products.
Role type
Senior IC PV Scientist with line management responsibilities
Builds
Safety signal detection, Risk Management Plans (RMPs), and aggregate safety reports (DSURs, PBRERs) for regulatory filings
Domain
Biopharmaceuticals / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Safety signal management, authoring Risk Management Plans (RMPs), writing aggregate safety reports (DSURs, PBRERs), regulatory response to health authorities, global filing safety sections, scientific data analysis and presentation
Preferred skills
Leading cross-functional safety forums, process improvement, mentoring PV teams
Technologies
None stated
Responsibilities
Oversee signal detection and management activities, lead authoring of Risk Management Plans and aggregate reports, respond to regulatory requests, manage and mentor a team of PV scientists, ensure compliance with global PV regulations
Seniority
Senior, hands-on IC with line management
