Associate Director of Drug Safety, Pharmaceutical Development and Manufacturing
St. Louis, MO

Global leader in the development of life saving pharmaceuticals seeks an Associate Director of Drug Safety to provide clinical and drug safety expertise in the development of new drug product and ensure continued safety of existing product. The Associate Director of Drug Safety will be responsible for ensuring safety assessment, analysis and reporting across the company's clinical development and post-marketign programs. A key responsibility will be ensuring accurate post-market pharmacovigilance reporting.

Job Requirements

M.D., or D.O. U.S. licensure REQUIRED. Industry or educational experience in Respiratory, Urologic, Cardiovascular or C.N.S. theraputic areas preferred
Pharmaceutical industry experience
Drug safety experience strongly preferred
Direct experience with regulatory reporting requirements for drug safety
Risk assesment and risk management strategic experience preferred
Graduate experience in public health or pharmacoepidemiology preferred
Working knowledge of GCP, U.S. IND and ICH regulations
Strong analytical skills with the ability to evaluate, interpret and synthesize data and prresent to company leadership
Strong leadership skills and the ability to work collaboratively in multi-functional teams
Project management skills

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