Director, Epidemiology - Pharmacovigilance and Risk Management job opportunity at BioPoint Inc.

Home Jobs In United States Tag: Epidemiology - Pharmacovigilance and Risk Management Director, Epidemiology - Pharmacovigilance and Risk Management position at BioPoint Inc


Date2014-11-12T17:04:29.000Z bot
BioPoint Inc Director, Epidemiology - Pharmacovigilance and Risk Management
Experience: General
Pattern: Full-time
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Epidemiology - Pharmacovigilance and Risk Management

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loacation Cambridge, Massachusetts, United States
loacation Cambridge, Mas..........United States
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Job DescriptionSummary:This position is responsible for all epidemiological aspects of pharmacovigilance and risk management activities for all company products. This position provides scientific input in risk evaluation and risk management planning and conducts epidemiological research and projects to further understand any potential risks, as well as to evaluate effectiveness of risk mitigation strategies after implementation. Analytical and pharmacoepidemiological skills are required, including an understanding of how to analyze customer scientific needs and translate them into outcome-oriented solutions. Responsibilities:Deliver highly experienced strategic input, epidemiological support and leadership to the pharmacovigilance and risk management teams at all stages of pharmaceutical development, to maximize the benefit-risk profile of company productsProactive identify clarify and resolve safety issues from an epidemiologic perspective in collaboration with the pharmacovigilance medical functionProvide timely epidemiologic input into regulatory and risk management reports including PSURs, labeling, Safety Monitoring Plans, REMS / Enhanced Pharmacovigilance Plans and Health Authority, and Expert Statements, Health Authority requestsProvide timely epidemiological and risk management support to project and product teams including design, implementation and analysis of epidemiological studies, review of study proposal from internal and external sources, analyses in adverse events reporting system databases (e.g. AERS, WHO), and interpretation and reporting on data analysisMaintains knowledge/expertise of existing large databases/data sources and new/emerging epidemiologic methodologies and techniques which may be suitable to conduct epidemiological evaluationsDesign, initiation, management, conduct, analysis, and reporting of epidemiological research projects in a global environmentConduct critical appraisal and synthesis of relevant epidemiological literaturePromote good epidemiological/pharmacoepidemiological practice and represent the company's position in any contacts with External Experts, Collaborative Groups or Contract Research Organizations

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