Global Patient Safety Pharmacoepidemiologist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Purpose:

The purpose of the Global Patient Safety Pharmacoepidemiologist (GPS PE), reporting into GPS Medical, is to provide scientific and data driven guidance to meet strategic objectives in the generation of data to characterize the safety profile of Lilly products. The GPS PE contributes to cross-functional teams that are responsible for generation of primary data or analysis of secondary data sources to contribute to the assessment of the benefit-risk profile of Lilly products.

The GPS PE is responsible for supporting the development and execution of risk management plans; identifying and evaluating potential safety signals, addressing safety questions from regulators, and designing and conducting pharmacoepidemiology studies. The GPS PE role may also entail some in-line or project-level supervisory 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. Not all listed responsibilities will be applicable to all GPS PE roles. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

• Collaborates within a cross-functional team and leads the design and execution of observational studies to ensure high quality, scientifically rigorous pharmacoepidemiology study proposals, protocols, statistical analysis plans, clinical study reports, abstracts/publications and/or presentations.
• Contribute to the Risk Management Strategy/Real World Evidence Safety Strategy for assigned molecule(s).
• Design, coordination, and implementation of observational epidemiological studies (including secondary use dataset studies) on epidemiology disease burden, natural history of disease, and assessment of background rates for identified/potential drug risks.
• Develop new methodologies and appropriately utilize pharmacoepidemiologic tools for the identification and analysis of potential safety signals; apply in-depth epidemiologic methods to address complex research questions.
• Lead the conduct of the pharmacoepidemiology studies internally (when appropriate) and collaborate/contract with external investigators and Third-Party Organizations as needed; provide scientific expertise in interpretation and communication of results of pharmacoepidemiology studies.
• Collaborate on developing strategic 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 analytic methods for selected regulatory safety documents/submissions (e.g., PBRER/PSUR, ISS, product labels).
• Provides input into regulatory documents such as Risk Management Plans, Periodic Benefit-Risk Evaluation Reports, and responses to regulatory queries.
• Provide epidemiological expertise as it…