Clinical Safety and Risk Management Associate Principal Scientist
Core
Primary medical review of serious adverse experience reports to monitor and describe the safety profile of assigned pharmaceutical products.
Role type
Associate Principal Scientist, Clinical Safety and Risk Management
Builds
Pharmacovigilance and risk management plans (RMPs) and regulatory safety documents
Domain
Pharmaceutical industry, Drug Safety, Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Causality assessment, Aggregate safety data analysis, Medical writing, Epidemiology, Clinical judgment, Regulatory compliance, Data analysis, Risk management strategy, Periodic Safety Update Reports (PSURs), Post-marketing surveillance
Preferred skills
Subject matter expertise in departmental programs and SOPS
Technologies
Database systems, MS Office suite
Responsibilities
Review individual adverse event reports and aggregate safety data; Prepare responses to safety inquiries from health professionals and regulatory agencies; Collaborate on the development and monitoring of Risk Management Plans (RMPs); Analyze data from IT systems to investigate safety issues; Participate in cross-functional teams for Risk Evaluation and Mitigation Strategies (REMS)
Seniority
Senior, hands-on IC
