At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Global Patient Safety Research Scientist / Consultant Scientist / Principal Research Scientist / Visiting Scientist, 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
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional
responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
This role requires a A PhD or DrPH in epidemiology.
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:
- A PhD or DrPH in epidemiology.
- 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.
Other Information/Additional Preferences:
- 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 GPS policies
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-16010.
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.
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