Senior / Director Drug Safety and Pharmocovilance

Senior Director, Drug Safety and Pharmacovigilance

The Senior Director, Drug Safety and Pharmocovilance is responsible for monitoring the safety profile including clinical assessment of a portfolio of drugs investigational and marketed according to the FDA regulations, ICH guidelines and corporate policies. It includes also the detection and evaluation of safety signals. These activities will be done in close collaboration with Clinical Operations and Regulatory Affairs and through the use of best quality and Pharmacovigilance practices. This position includes the management of other professionals in this department. M.D. degree is required. Board Certification in a medical specialty or a foreign medical degree and 3-5 years of US industry experience in Safety Surveillance, Pharmacovigilance or Drug Safety. A minimum of 2-4 years of clinical practice experience in a relevant setting are preferred. Critical care, anesthesiology, pulmonology or infectious disease background is essential. Experience in or knowledge about drug-development procedures. Experience in regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance and knowledgeable in the use of MedDRA are required.

Currently at Phase III clinical trials looking for someone to rport in to the CMO and lead signature meetings and manage 2 other PV specialists bigger pharma co experiance is desired

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