Senior Director of Drug Safety

A company is looking for a Senior Director, Drug Safety and Pharmacovigilance.

Key Responsibilities

Oversee the safety profile of assigned products from clinical development to post-approval safety surveillance

Facilitate Safety Management Committees 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

Bachelor's degree in a healthcare discipline; 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 submissions for NDAs and EU MAAs

Knowledge of GCP, FDA regulations, and ICH guidelines

Experience with clinical trial safety databases and reporting generation