What are the responsibilities and job description for the Global Head of Risk Management position at Regeneron Pharmaceuticals?
Responsibilities:
Develop and implement safety strategies for molecules in clinical development and post-marketing phases
Oversee signal detection activities according to approved safety surveillance plans
Evaluate identified signals and author comprehensive safety evaluation reports
Prepare and review critical safety documents, including DSUR, PSUR, RMP, and responses to health authority queries
Represent the Global Patient Safety team on cross-functional teams, including Regeneron's Safety Oversight Committee and Independent Data Monitoring Committees
Contribute to process improvement initiatives by developing and maintaining relevant SOPs, WIs, and supporting documents
