Case Manager- Case Management Operations

Benefits

Additional Information

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 Manager is responsible for the compliant processing of Individual Case Safety Reports (ICSRs) within the safety system for all Lilly compounds and products in accordance with global pharmacovigilance regulations and company standards ensuring data integrity, quality, consistency, and compliant safety reporting. This individual contributor role performs specialized tasks within the case management workflow, which may include intake and triage activities, case processing (data entry, coding, narrative writing), or reporting and submissions, depending on team assignment. This role reports through a Group Leader, Case Management Operations. 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. Core Responsibilities (All Team Assignments) Process ICSRs accurately and efficiently within established timeframes and quality standards (e.g., peer review of individual cases, aggregate review of cases in queries) Follow all applicable SOPs, work instructions, and regulatory requirements Apply safety database systems (e.g., Argus, Veeva) effectively for assigned tasks Maintain high quality standards with attention to detail and accuracy Advance complex cases, questions, or issues to management appropriately Engage in training programs and maintain competency in assigned functional areas Contribute to innovative initiatives and recap on process optimization Support audit and inspection activities by maintaining proper documentation Collaborate effectively with team members and cross-functional partners Mentor junior case managers Adhere to data privacy and confidentiality requirements May collaborate in special projects as needed Specialized Responsibilities by Team Assignment: Intake and Triage Team: Receive and acknowledge adverse event reports from all sources (spontaneous, clinical trials, literature, digital media, etc.) Perform initial case assessment to determine if minimum criteria for a valid ICSR are met Triage cases based on seriousness, expectedness, regulatory timelines, and medical vitality Route cases to appropriate processing queues or medical review pathways Initiate follow-up for invalid or incomplete case information Document receipt of information and complete intake forms/checklists Perform literature screening and case identification from monitored publications Process duplicate case assessments and case linking activities Coordinate with Medical Information, affiliates, and other case sources for information clarification B. Case Processing Team: Enter complete case information from source documents into the safety database Apply MedDRA coding to adverse events using appropriate Lower Level Terms (LLTs) and Preferred Terms (PTs) Apply WHO-DD coding to medications/products with accurate formulation and indication Assess case seriousness, expectedness, and causality (where applicable) according to defined criteria Write clear, concise, and scientifically accurate case narratives Perform case assessments including clinical relevance and data consistency checks Generate and follow-up queries for additional information Link cases appropriately (duplicate, parent-child, case series) Process special case types including pregnancies, medication errors, off-label use, lack of efficacy, legal Perform in-line quality control checks prior to case finalization Prepare cases for medical review ensuring all required elements are complete C. Reporting and Submissions Team: Reporting and Submissions Team: Generate expedited reports (ICSRs) for health authorities per regulatory timelines (15-day, 7-day) Create initial and follow-up submissions in required formats (E2B, CIOMS, local formats) Prepare and submit reports to business partners per pharmacovigilance agreements Generate investigator and ethics committee safety notifications for clinical trial cases Perform pre-submission quality checks ensuring accuracy and completeness Submit reports through regulatory gateways and track transmission confirmations Process acknowledgments from health authorities and document successful submissions Generate nullifications and amendments for previously submitted reports when required Maintain reporting logs and ensure acc