Director - Case Management Medical Review

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.

Minimum Qualification Requirements

• 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).
• OR
• 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).
• Experience in the drug development process
• Fluent in English, both written and verbal communication

Other Information/Additional Preferences

• Advanced medical related graduate degree, such as: DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years' experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field.
• Clinical development or pharmacovigilance experience preferred
• Experience with KPI's, metrics and dashboards
• 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 (both cross-functionally and within the function) in order to create a positive working environment.
• Excellent teamwork skills.
• Strategic thinking.
• Demonstrated success in implementing projects and/or innovating.
• Receptive, engaging, and impactful contributor.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$148,500 - $257,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.