Case Management Medical Review Physician

Role Summary

The Case Management Medical Review Physician 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).

Responsibilities

• Conduct comprehensive ICSR medical reviews across all therapeutic areas, ensuring high-quality outcomes and adherence to regulatory timelines. Include medical validity of ICSRs; 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, monitor ICSRs for potential emerging safety concerns, and identify or support evaluation of potential quality issues with Lilly products that may affect patient safety.
• Collaborate with cross-functional teams on case management, audit and inspection readiness, regulatory responses, and causality assessments; liaise with GPS teams to monitor surveillance terms for marketed products.
• Develop cross-functional foundations for GPS activities (e.g., aggregate review and signal detection, Safety Topic Reports, regulatory requests due diligence, protocol authoring).
• Influence others 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 gaps and retraining needs as appropriate.
• Remain informed on marketed portfolio and development pipeline; drive scientific and process improvements and contribute to organizational change.
• 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, 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.
• Author, review, and approve SOPs and support/lead activities for training and implementation of updated or new processes; act as point of contact for Health Authority Inspections or Internal Process Audits and lead corrective actions and preventive measures.
• Understand the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (QPPV) and provide support to enable the QPPV to fulfil legal responsibilities.
• Maintain up-to-date knowledge of medical guidelines, regulations, and industry best practices; interpret evolving regulatory environments and their impact on case management and medical review practices.
• Comply with all compliance policies, laws, regulations, and the Red Book; adapt to changing global regulatory environment; perform other duties as defined in SOPs or as work evolves.

Qualifications

• Required: Medical Doctor or Doctor of Osteopathy; board eligible or certified in appropriate specialty/subspecialty or completed comparable level of post-medical school clinical training relevant to the country of hiring.
• Required: US trained physicians must have achieved board eligibility or certification. Foreign medical graduates (in US based jobs) not US board eligible/certified may be hired at the discretion of the Chief Medical Officer.
• Required: Non-US trained physicians must have completed education and training at a medical school substantially equivalent to LCME-accredited programs; see regulatory guidelines for foreign medical schools as applicable.

Skills

• Fluent in English with highly effective written and verbal communication skills.
• Strong clinical/diagnostic skills; solid understanding of pharmacovigilance and clinical research principles.
• Excellent interpersonal, organizational, and negotiation skills; ability to work on multiple projects in a fast-paced matrixed environment.
• Ability to prioritize tasks, shift priorities rapidly to meet deadlines, and influence cross-functional teams to create a positive working environment.
• Excellent teamwork and collaboration abilities; strategic thinking and demonstrated success in implementing projects or innovations.

Additional Requirements

• Willing to engage in domestic and international travel to support the business of the team.