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Details

Pharmacoepidemiologist


Reference:SCAQOA-012657 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Doctor (Medical), PhD

Pharmacoepidemiologist
Our client a global pharma organisation are currently recruiting for a Pharmacoepidemiologist to join their team on a permanent basis. As Pharmacoepidemiologist you 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.

Responsibilities
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 Global Patient Safety Surveillance Teams. Demonstrate understanding of the roles and responsibility of the EU QPPV. Support audit readiness.

Support Risk Management Planning
• Provide epidemiology expertise to support compounds in development, new product launches, and existing marketed products; partner/collaborate with various teams 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.

Characterize Natural History of Diseases
• Provide support to teams across the organisation 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 organisation 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.

Collaborate with Internal and External Customers
• Communicate effectively with relevant internal business partners; collaborate with relevant teams as part of issue management and in preparation of responses to requests posed by regulatory authorities; support relevant teams regarding safety information requests and other safety activities; collaborate with external partners and participate on key external initiatives.

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

Supervisory Responsibilities
• The role may also entail line supervisory or contract-employee responsibilities for a small group of Epidemiologists, 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.

Requirements:

  • A PhD or DrPH in epidemiology
  • Clinical background (e.g., PharmD, MD, RN)
  • Experience conducting epidemiological studies
  • High-level knowledge of global regulations with respect to drug safety and adverse event reporting
  • High-level knowledge and good understanding of Global Patient Safety policies
  • Ability to conduct epidemiology research including preparation of study protocols and statistical analysis plans
  • Competent in the independent analysis of data from clinical and epidemiology studies
  • Excellent computer skills; knowledge of SAS, SPSS, Epi Info, and/or equivalent statistical software package
  • Have strong analytic skills, oral and written communication skills, strong interpersonal and leadership skills, and able to work independently and as a team member to resolve a variety of drug safety issues