Senior Director, Pharmacovigilance

Job Summary

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

Key Responsibilities

• Chair the Safety Risk Management Team to evaluate and manage safety signals and risks
• Contribute to safety-related sections of clinical study documents and provide expert guidance on global regulations
• Lead regulatory authority interactions and support safety data exchange agreements with partners

Required Qualifications

• Medical degree (MD/DO), PharmD, or equivalent required, with at least 2 years of clinical/medical practice experience
• 10+ years of related experience, preferably in global pharma/biotech
• Experience in authoring safety signal assessment reports and managing safety information
• Knowledge of global regulations and ICH guidance governing pharmacovigilance and risk management
• Experience leading cross-functional Safety Risk Management Teams