Pharmacovigilance Scientist
Core
Safety expert responsible for performing core pharmacovigilance activities, identifying safety signals, and analyzing safety data for marketed products and those in clinical development.
Role type
Pharmacovigilance Scientist (PVS)
Builds
Safety evaluations, signal detection reports, and risk management plans for the One Rare Disease portfolio.
Domain
Biopharmaceuticals / Pharmacovigilance
Deliverable
client delivery
Required skills
Signal detection, safety data analysis, regulatory filing support, risk assessment, presentation facilitation, outsourced activity coordination
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage proactive signal detection and safety management committee activities; Coordinate and author safety evaluations and responses to safety inquiries from internal or external stakeholders; Drive end-to-end signal management process for assigned products; Serve as a core member of the Safety Management Team to produce data/outputs and present safety analysis; Partner with the Safety Team to manage safety activities for new drug applications and benefit-risk assessment; Coordinate and oversee outsourced activities.
Seniority
Individual Contributor
