Sr Director, Pharmacovigilance (Pharmacoepidemiology)

Job Category: Biotech/R&D/Science Career Level: Executive (SVP, VP, Department Head, etc) Quintiles Strategic Research Services is a global business dedicated to supporting commercialization of healthcare technologies through strategic research (late phase clinical studies, health outcomes research, and consulting services).  We are currently seeking a Sr. Director, Pharmacoepidemiology to join our team!This positon will  provide outcomes and epidemiology expertise to the field of Benefit-Risk Assessment and Risk Management, including the following activities: ·  Ability to interpret patient-reported outcomes data including validation statistics·  Contribute epidemiologic input to the development of Protocols ·  Create epidemiology strategy and apply optimal epidemiologic methodology to clinical safety investigation, risk management, and benefit-risk  assessment; create and oversee epidemiologic studies to evaluate safety risks for   projects and products·  Lead the development, implementation and ongoing evaluation of epidemiology   projects and risk management programs·  Analyse adverse event data for the purpose of signal detection·  Research experience in the areas of pharmacoepidemiology, health services research or observational studies·  Experience in pharmacovigilance and drug safety, risk management and/or signal   detection·  Provide epidemiologic input to Safety Review Committees·  Design and oversee epidemiologic studies for the purpose of signal evaluation·  Design and oversee epidemiologic studies to determine background rates of diseases, symptoms, and syndromes and to characterize the natural history of a disease·  Provide epidemiologic input into risk management programs of various types ·  Provide epidemiologic input into regulatory reports such as safety update reports, labeling justifications Risk Management Plans and Pharmacovigilance Plans·  Provide epidemiology support for proposals to customers, including epidemiology studies and safety studies  Post-graduate degree in Epidemiology or similar degree (e.g., MPH) — doctorate level preferred, and MD as additional degree preferred.  At least 8 years experience as an epidemiologist in the Pharmaceutical industry and/or a regulatory agency (e.g., FDA, EMEA).  Experience writing and/or reviewing Risk Management Plans and with epidemiologic evaluation of drug safety issues across multiple therapeutic areas.  Expertise in Pharmacoepidemiology and patient reported outcomes as evidenced by having authored epidemiologic study reports in scientific journals.  Excellent verbal and written communication skills.  Proficiency with standard technology tools such as SAS and Microsoft Office.  Experience in project management, including budget management, and/or experience in personnel management.  Experience and proficiency in working in multidisciplinary teams and cross-cultural/global teams.  Excellent knowledge of FDA and European Drug Safety regulations.  Experience in interacting with Regulatory Agencies.