PV Scientist
Core
Perform signal management activities and author comprehensive safety evaluations to ensure product safety and efficacy.
Role type
Senior IC Pharmacovigilance Scientist (Signal Management & Reporting)
Builds
Aggregate safety reports (PSURs, DSURs, Risk Management Plans) and regulatory responses
Domain
Biotechnology / Pharmacovigilance
Required skills
Pharmacovigilance signal detection, safety data evaluation, safety literature review, regulatory response authoring, protocol review, data analysis, process improvement, global safety regulations knowledge, scientific/medical data interpretation
Preferred skills
Safety database systems experience, advanced degree (PhD, MPH, NP, PharmD)
Technologies
Excel, PowerPoint, Microsoft Word, Business Objects
Responsibilities
Author aggregate safety reports (PSURs, DSURs, Risk Management Plans), track and evaluate new safety signals, conduct safety literature reviews, coordinate regulatory responses, review clinical trial protocols, lead process improvement initiatives
Seniority
Senior, hands-on IC