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 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. Purpose: The Case Management Medical Review Scientist is responsible for conducting comprehensive medical review of Individual Case Safety Reports (ICSRs), ensuring the accuracy, integrity, and compliance of global regulatory reports, and for collaborating cross functionally and providing technical leadership within Case Management and across Global Patient Safety (GPS). 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 role/position can change over time and can include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position. Medical review of ICSRs Conduct comprehensive ICSR medical reviews across all therapeutic areas, ensuring high-quality outcomes and adherence to regulatory timelines. Including: Ensuring medical validity of ICSRs; Accountable for the review and accuracy of narratives, coding, and assessments of seriousness, expectedness, and company causality; Complete medical review and follow-up of ICSRs per SOPs for CT and MP cases. Promptly escalate significant cases and safety issues, while closely identifying and monitoring ICSRs that could indicate potential emerging safety concerns. Identify or support evaluation of potential quality issues with Lilly products that may adversely affect patient safety. Collaborate effectively with cross-functional teams on topics including case management, audit and inspection readiness, regulatory responses, and causality assessments. Liaise with GPS teams to monitor and remain updated on surveillance terms for marketed products. Leadership for GPS Develop cross-functional foundations (e.g., aggregate review and signal detection, Safety Topic Reports, regulatory requests due diligence, protocol authoring, etc.). Influence others (both cross-functionally and within the function) to meet business objectives and safeguard patient safety while maintaining a positive working environment. Provide medical and regulatory guidance to cross-functional teams to enable completion of case management and medical review work. Provide training, coaching and mentorship to GPS scientists and physicians with respect to clinical and safety science. Identify areas of gaps and retraining needs as appropriate. Remain informed and up to date up to date on marketed portfolio and development pipeline. Drive scientific and process improvements and contribute to organizational change Support Operational Management and Oversight Coordinate and monitor workflows to ensure timely, compliant case reviews. Track capacity and KPIs, analyze trends, identify risks, and propose solutions for senior leadership decisions. Drive meeting agendas, manage action items, and ensure effective follow-up. Support prioritization and resource optimization through financial and capacity analysis. Enhance processes, ensure audit readiness, and enable training for qualified medical reviewers. Standards and Inspection Readiness Author, review, and approve SOPs and support/lead activities for the training and implementation of updated or new processes. Be point of contact for Health Authority Inspection or Internal Process Audits and ability to participate in back and front rooms, prepare responses (written/verbal), and lead corrective actions and preventive measures. Understanding and support of the QPPV role Understand the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV). Ensure support is provided to enable the QPPV to fulfil the QP legal responsibilities. Other Job expectations Maintain up-to-date knowledge of medical guidelines, regulations, and industry best practices that inform Medical Review work. Present strong understanding of pharmacovigilance and clinical research principles, regulations, and be able to interpret complex situations and assess impact of evolving regulatory environment to case management and medical review practices. Understand and comply with all compliance policies, laws, regulations, and the Red Book. Adapt to the changing global regulatory environment. Perform other duties related to the position as necessary as defined in SOPs or as work evolves. A Case Management Medical Review Scientist is expected to meet the criteria as outlined in the global path job criteria for the appropriate R path levels. For each level on every global path, there is a consistent set of job criteria which includes functional and technical expertise, decision making, influence, and problem solving.