Pharmacoepidemiologist - Global Patient Safety

Employer
Location
Indianapolis
Salary
Competitive
Posted
February 07 2017
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
Purpose of the Job:

Within Lilly, GPS Pharmacoepidemiology delivers meaningful application of pharmacoepidemiology results to stakeholders (SMTs, development teams, medical affairs, regulators, payers, HCPs, and ultimately, patients) to advance the development of new medicines with a positive benefit/risk profile and to optimize safe use of medications in patients. 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 risk management responsibilities: directly support the development and execution of risk management plans; lead / contribute to the design, execution and assessment of specialized risk minimization activities (as appropriate); identify and evaluate potential safety signals and address safety questions from regulators. The Epidemiologist will also 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.

Key Objectives:

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). Basic Qualifications
  • A PhD or DrPH in epidemiology or other subject with high epidemiologic content.
  • Applicant must have at least 1+ years post-doctoral pharmaceutical industry experience in a pharmaceutical company or CRO as a pharmacoepidemiologist/epidemiologist
Additional Skills/Preferences
  • 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.
  • 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 be able to work independently and as a team member to resolve a variety of drug safety issues
  • Clinical background (e.g., PharmD, MD, RN)
  • High-level knowledge of global regulations with respect to drug safety and adverse event reporting
  • High-level knowledge and good understanding of GPS policies
Additional Information
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.