Senior Director, US Risk Management & Product Safety (REMS)
Core
Lead US safety strategy for a portfolio of complex medicines, overseeing REMS design, FDA engagement, and risk management execution.
Role type
Senior Director, US Risk Management & Product Safety (REMS)
Builds
US REMS programs, risk minimization measures, and safety reporting systems
Domain
Pharmaceutical industry, US regulatory compliance, Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
REMS strategy leadership, FDA regulatory compliance, risk management planning, vendor performance management, safety labeling oversight, aggregate safety reporting, audit/inspection readiness, executive leadership
Preferred skills
Advanced degree (PharmD, PhD, MD), familiarity with safety databases and REMS platforms
Technologies
REMS platforms, safety databases, data analytics tools
Responsibilities
Lead US REMS Safety Strategy aligned with FDA requirements; Drive development and launch of innovative REMS programs; Manage REMS vendor performance and data integrity; Oversee US safety labeling and aggregate report submissions; Maintain readiness for regulatory inspections and audits; Participate in FDA interactions and advisory boards
Seniority
Senior Director, strategic leadership & execution
