Director of Drug Safety

Job Summary

A company is looking for a Sr. Director, Scientist.

Key Responsibilities

• Oversee all aspects of the assigned product's safety profile, including management of CROs and safety data
• Facilitate Safety Management Committee for designated products and recommend safety actions based on data
• Collaborate with regulatory and clinical teams to establish safety strategies for marketing authorization applications

Required Qualifications

• Bachelor's degree in a health care discipline or equivalent; advanced degree preferred
• At least ten years of drug safety and pharmacovigilance experience, with five years in Clinical Development Safety
• Extensive experience in safety signal evaluation and regulatory correspondence
• Experience with regulatory submissions for NDAs, EU MAAs, and post-marketing safety
• Familiarity with clinical trial safety databases and Microsoft Office Suite