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

Support Operational Management and Oversight

Standards and Inspection Readiness

Understanding and support of the QPPV role

Other Job expectations

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.

Minimum Qualification Requirements :

Other Information / Additional Preferences :

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.

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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.

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