Senior Director Pharmacovigilance Risk Management

Job Summary

A company is looking for a Senior Director, Global Pharmacovigilance & Risk Management-Medical Safety.

Key Responsibilities:

• Chair cross-functional Safety Risk Management Team (SRMT) to review safety data and develop risk management strategies
• Contribute to safety-related sections of clinical study documents and provide expert guidance internally and externally
• Perform medical review of Individual Case Safety Reports and aggregate safety reports

Qualifications:

• Medical degree (MD/DO), PharmD, or equivalent with 2 years of clinical/medical practice experience
• 10+ years of related experience in global pharma/biotech preferred
• Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI
• Experience with global regulations and ICH guidance in pharmacovigilance and risk management
• Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding