Director - Global Patient Safety Pharmacoepidemiologist

Minimum Qualification Requirements

• Graduate-level degree in a health-related field and 3+ years of experience in scientific research or the pharmaceutical industry.
• Experience conducting epidemiology studies, including analyzing data and interpreting results from clinical and epidemiology studies.
• Experience with AI-driven programming techniques to enhance pharmacoepidemiologic study design, data analysis, and signal detection activities.

• Collaborate within a cross-functional team and lead the design and execution of observational studies, ensuring high-quality, scientifically rigorous study proposals, protocols, statistical analysis plans, clinical study reports, abstracts/publications, and presentations.
• Contribute to the Risk Management Strategy/Real World Evidence Safety Strategy for assigned molecule(s).
• Design, coordinate, and implement observational epidemiological studies (including secondary use dataset studies) on disease burden, natural history of disease, and background rates for identified or potential drug risks.
• Develop new methodologies and appropriately use pharmacoepidemiologic tools to identify and analyze potential safety signals.
• Apply in-depth epidemiologic methods to complex research questions.
• Lead pharmacoepidemiology studies internally when appropriate, and collaborate or contract with external investigators and Third-Party Organizations as needed.
• Provide scientific expertise in interpreting and communicating study results.
• Collaborate on strategic analytic tools that support disease state characterization, signal detection, clarification, and evaluation using multiple data sources (e.g., spontaneous reports, health claims, electronic health records).
• Partner on new standardized analytic methods for selected regulatory safety documents and submissions (e.g., PBRER/PSUR, ISS, product labels).

• Provide input into regulatory documents such as Risk Management Plans, Periodic Benefit-Risk Evaluation Reports, and responses to regulatory queries.
• Provide epidemiological expertise on signal detection and signal management for the portfolio.
• Collect and analyze patient population data from literature and other sources to assess disease burden in support of regulatory submissions (e.g., Orphan Drug Applications, Pediatric Investigation Plans, Pediatric Study Plans).
• Represent Lilly and coordinate its presence in external epidemiology or drug safety groups.
• Stay current on regulatory activities (e.g., FDA, EMA) related to epidemiology.
• Use external contacts for scientific intelligence through benchmarking projects and forums.

• Maintain a deep understanding of RWD and methodology, including digital tools.
• Demonstrate knowledge of relevant global regulatory requirements and practices.
• Act as subject matter expert in developing and maintaining procedures and required tools in the quality system as they relate to epidemiology.
• Develop analytic tools that support disease state characterization, signal detection, clarification, and evaluation using multiple data sources (e.g., spontaneous reports, health claims, electronic health records).
• Partner on new standardized analytic methods for selected regulatory safety documents and submissions (e.g., PBRER/PSUR, ISS, product labels).

• Support strategy across the product lifecycle through evidence generation.
• Contribute to the Risk Management Strategy/RWE Safety Strategy for a molecule.
• Design, execute, and interpret pharmacoepidemiology studies, including design and review of protocols, SAPs, final study reports, presentations, and manuscripts.
• Lead pharmacoepidemiology studies internally when appropriate, and collaborate or contract with external investigators and CROs as needed.
• Provide scientific expertise in interpreting and communicating study results.

• Provide training, coaching, and mentorship on effective PV strategies, sharing experience and knowledge to advance the goals of the GPS department and the wider enterprise.
• Maintain compliance with the Lilly Red Book, corporate policies, and the Lilly Research Laboratories and Global Patient Safety curriculum.
• Maintain compliance with the Lilly Corporate Integrity Agreement.

• Foster 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.
• Ensure staff comply with company policies and procedures.

• Understand the roles and responsibilities of the European Union Qualified Person (QPPV).
• Ensure the support needed for the Qualified Person to fulfill all of their legal responsibilities.