Senior Medical Director, Drug Safety

Job Summary

A company is looking for a Sr. Medical Director, Drug Safety.

Key Responsibilities

• Oversee the safety profile of assigned products from clinical development to post-approval safety surveillance
• Chair the Safety Management Committee to identify safety trends and recommend actions based on safety data
• Collaborate with regulatory and clinical teams to establish safety strategies for marketing authorization applications

Required Qualifications

• Medical Degree
• 10 years of drug safety and pharmacovigilance experience, preferably in biotechnology or pharmaceuticals
• Experience with safety signal evaluation and regulatory submissions for NDAs and EU MAAs
• Familiarity with both clinical development and post-marketing safety
• Experience managing clinical trials safety data and collaborating with cross-functional teams