Senior PV Scientist
Core
Lead safety signal management, aggregate reporting, and regulatory response for marketed products and clinical trials.
Role type
Senior IC pharmacovigilance scientist (product lead)
Builds
Safety signal evaluation reports, aggregate safety documents (PSURs, DSURs, RMPs), regulatory responses
Domain
Life sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Safety signal detection and management, Aggregate report strategy and finalization, Medical and scientific literature review, Regulatory authority response drafting, Clinical trial safety oversight, Data analysis and interpretation
Preferred skills
Global safety regulations expertise, Staff mentoring and management, Clinical judgment in data interpretation
Technologies
Excel, PowerPoint, Microsoft Word, Business Objects, Safety database systems
Responsibilities
Conduct ongoing safety data reviews and signal detection activities, Lead signal management activities for assigned products, Manage literature review activities to identify safety information, Oversee aggregate report management, Prepare responses to safety questions from regulatory authorities, Collaborate with Global Safety Officers and Safety MDs on clinical trial activities
Seniority
Senior, hands-on IC with management responsibilities
