Associate Director, Drug Safety (PVRM)

Position Summary:Be the safety physician for the assigned Forest Products (both investigation and marketed) and responsible for monitoring of the safety of these products. Be part of the team of PVRM physicians in DSS, reporting into the Executive director for PVRM.Duties and Responsibilities:·         Review individual case reports on serious events for medical accuracy and adequacy; determine causality for clinical trial cases·         Review the required periodic reports to the FDA·         Perform signal evaluation using a signal generation tool ·         Participate in the clinical development teams·         Generate and maintain adequate representation of the safety data in the product label·         Generate risk management plans when applicable ·         Initiate relevant review upon potential signals for safety issues, generate ad-hoc analyses, documents and ‘white papers’ on potential safety issues.Requirements:·         MD or DO required·         Preferably  Clinical patient care experience·         Preferably 5 years of Pharmaceutical Industry experience·         Preferably 3 years of Drug Safety Experience·         Understanding of regulatory requirements (FDA, ICH)·         Analytical thinking·         Good verbal and written communication skills·         Organizational skills