Director - Case Management Medical Review

Role Summary

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).

Responsibilities

• Medical review of ICSRs
  • Conduct comprehensive ICSR medical reviews across all therapeutic areas, ensuring high-quality outcomes and adherence to regulatory timelines.
  • Ensuring medical validity of ICSRs; account 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, 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/inspection readiness, regulatory responses, and causality assessments.
  • Liaise with GPS teams to monitor 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).
  • 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; identify gaps and retraining needs as appropriate.
  • Remain informed about 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 training and implementation of updated or new processes.
  • Be point of contact for Health Authority Inspections or Internal Process Audits; participate in preparations and lead corrective actions and preventive measures.
• Understanding and support of the QPPV role
  • Understand the roles and responsibilities 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; interpret complex situations and assess impact of evolving regulatory environment on 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 as defined in SOPs or as work evolves.

Qualifications

• Required: PhD with 3+ years of pharmaceutical industry experience and clinical trial experience, or experience in drug discovery or development (e.g., epidemiology, toxicology, pharmacovigilance, regulatory affairs).
• Required: BS degree (or equivalent experience) in a health-related field with 10+ years of pharmaceutical industry experience and clinical trial experience, or experience in drug discovery or development (e.g., epidemiology, toxicology, pharmacovigilance, regulatory affairs).
• Required: Experience in the drug development process.
• Required: Fluent in English, both written and verbal communication.

Education

• PhD or BS with corresponding experience as noted in qualifications.

Skills

• Strong clinical/diagnostic skills.
• Excellent interpersonal, organizational, and negotiation skills.
• Ability to work on multiple projects and function effectively in a fast-paced matrixed environment.
• Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines.
• Ability to influence others cross-functionally to create a positive working environment.
• Excellent teamwork skills and strategic thinking.
• Demonstrated success in implementing projects and/or innovating; receptive, engaging, and impactful contributor.