Global Patient Safety Pharmacoepidemiologist

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. 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. Study Design & Execution-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).Regulatory Support and Public Health Impact-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 relates to signal detection and signal management for the portfolio.-Collect and analyze patient population data from literature/other sources to assess disease burden providing support for regulatory submissions (e.g., Orphan Drug Applications, Pediatric Investigation Plans, or Pediatric Study Plans).-Represent Lilly and coordinate its presence in external epidemiology or drug safety groups.-Stay updated on regulatory activities (eg, FDA, EMA) related to epidemiology.-Use external contacts for scientific intelligence through benchmarking projects and forums. Data Source Expertise-Deep understanding of RWD and methodology including digital tools.-Demonstrate knowledge of relevant global regulatory requirements and practices; act as subject matter expert in the development and maintenance of procedures and required tools in the quality system as they relate to epidemiology.-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 analytic methods for selected regulatory safety documents/submissions (e.g., PBRER/PSUR, ISS, product labels).Lifecycle Management-Support strategy across lifecycle through evidence generation.-Contribute to the Risk Management Strategy/RWE Safety Strategy for a molecule.-Design/execution/interpretation of pharmacoepidemiology studies including design and review of study protocols, SAPs, final study reports, presentations, and manuscripts.-Lead the conduct of the pharmacoepidemiology studies internally (when appropriate) and collaborate/contract with external investigators and CROs as needed; provide scientific expertise in interpretation and communication of results of pharmacoepidemiology studies. Training, Coaching, Mentoring-Provide training, coaching and mentorship demonstrating effective PV strategies and sharing experience and knowledge to further advance the goals of the GPS department and wider enterprise.-Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum.-Maintaining compliance with the Lilly Corporate Integrity Agreement. People Management-Foster and support a collaborative working environment that maintains a Team Lilly culture focused on inclusion, innovation, acceleration, and delivery.-Recruit, mentor, develop, and retain top scientific and drug development talent.-Assure staff comply with company policies and procedures. Understand and support the QPPV role-Understanding the roles and responsibilities of the European Union Qualified Person (QPPV).-Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.