LOCATION : CORK, IRELAND ***
(This role requires a A PhD or DrPH in epidemiology)
The purpose of the Global Patient Safety (GPS) Epidemiologist is to provide pharmacoepidemiology leadership and technical support to the GPS Organization, EPM/Transition/GBD Teams, Health Outcomes, Affiliates, and other functional areas within the Company. As part of a cross-functional team, the Epidemiologist will have the following responsibilities: support the development and execution of risk management plans; identify and evaluate potential safety signals and address safety questions from regulators.
The Epidemiologist will have primary responsibility for designing and conducting pharmacoepidemiology studies using appropriate methods and data sources; for understanding the natural history of targeted health conditions; and for collaborating with external research organizations.
The Epidemiologist role may also entail some inline or project-level supervisory responsibilities
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; design pharmacoepidemiology studies, work with external investigators and CROs; review and develop study protocols; conduct and manage pharmacoepidemiology studies; 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
4. Collaboration with Internal and External Customers
• 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.
• 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. Strategic Development of Analytic Tools
• Develop analytic tools 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
6. Supervisory Responsibilities
• The role may also entail line supervisory or contract-employee responsibilities for a small group of Epidemiologist, including implementation of organizational objectives, putting in place and ensuring execution of performance
management and development plans, performance assessment, coaching, addressing human resource related issues, providing scientific guidance and project oversight, ensuring compliance with SOPs and regulations, implementation of functional coordination/standardization across projects, and building staff capacity or optimizing productivity.
The supervisory responsibilities may require up to 25-30% of the epidemiologist’s time; the remaining 70-75% will focus on direct product support and technical/scientific activities.
Minimum Qualification Requirements:
Other Information/Additional Preferences:
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