Director of Safety Science

A company is looking for a Director or Sr Director, Safety Science.

Key Responsibilities

Develop and maintain an understanding of the safety profile of assigned product(s) and relevant strategic context

Provide Safety Science leadership for clinical development programs and integrate safety science strategy with clinical development plans

Contribute to regulatory authority submissions and represent Medical Drug Safety in communications with health and regulatory authorities

Required Qualifications

Healthcare professional degree required; MD or PharmD highly preferred

6+ years of drug development experience in the pharmaceutical industry, including 4 years in drug safety for oncology clinical development

Broad understanding of safety, pharmacovigilance, and clinical / patient risk management

Expert knowledge of regulations governing pharmacovigilance

Experience interacting with regulatory authorities at various meetings; filing experience preferred