Job Description
Position Summary
As a Medical Director for Clinical Trial/Research Safety you will provide expert safety leadership and input to clinical development programs for nutritional solutions and therapeutics across the lifespan, and ensure safety compliance with regulatory frameworks applicable to pharma, medical nutrition and food for medical purposes (FSMP).
A Day in the Life of a Medical Director Safety
- Responsible for building safety assessments and safety management plans optimized for trial design, conduct signal detection, monitoring, evaluation, interpretation and appropriate management & reporting of safety information such as annual safety reports, based on data from all relevant sources.
- Lead safety input to Data Safety Monitoring Boards charters, aggregate safety reports (DSUR/ASR where applicable), and risk management plans; contribute to Safety & Risk Management Team (SRMT) and signal review forums.
- Coordinate the mana...