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Research Scientist - Pharmacoepidemiology
1: Global Patient Safety Support
Demonstrate knowledge of relevant global regulatory requirements and practices; act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to epidemiology; and provide pharmacoepidemiology support to GPS Surveillance Teams. Demonstrate understanding of the roles and responsibility of the EU QPPV. Support audit readiness.
2: Support Risk Management Planning
Provide epidemiology expertise to support compounds in development, new product launches, and existing marketed products; partner/collaborate with both EPM/Transition/GBD Teams and GPS TA physicians on the development of risk management plans ; lead / contribute to the design, execution, and assessment of specialized risk minimization activities (as appropriate) ; design, conduct, and manage pharmacoepidemiology studies; work with external investigators and CROs; review and develop study protocols; use population-based health statistics and electronic health information databases (e.g., national mortality rates, GPRD, and health claims databases) in evaluating safety issues.
3: Characterize Natural History of Diseases
Provide support to EPM/Transition/GBD Teams and GPS TA physicians with patient population data from the literature or other relevant data sources to understand the nature and burden of illness of various disease/conditions for which the Company is developing new products to treat or to prevent; conduct and manage epidemiology studies to characterize disease trends, frequencies, incidence/prevalence, co-morbidities, outcomes, risk factors and treatments.
4: Collaboration with Internal and External Partners
Communicate effectively with relevant internal business partners; collaborate with EPM/Transition/GBD Teams and Regulatory Scientists as part of issue management teams and in preparation of responses to requests posed by regulatory authorities; support EPM/Transition/GBD Teams regarding safety information requests and other safety activities; collaborate with external partners and participate on key external initiatives.
5: Real World Evidence - Analytics
Develop analytic tools and methods to support activities such as disease state characterization, signal detection, clarification, and evaluation utilizing multiple data sources (e.g., spontaneous, health claims and electronic health records); partner on the development of new standardized analytic methods for selected regulatory safety documents/submissions (e.g., PSUR, ISS, product labels).
A PhD or DrPH in epidemiology or other subject with high epidemiologic content.
Applicant must have at least 3 years post-doctoral pharmaceutical industry experience in a pharmaceutical company or CRO as a pharmacoepidemiologist/epidemiologist.
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