Case Manager- Case Management Operations

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 requirementsApply safety database systems (e.g., Argus, Veeva) effectively for assigned tasksMaintain high quality standards with attention to detail and accuracyAdvance complex cases, questions, or issues to management appropriatelyEngage in training programs and maintain competency in assigned functional areasContribute to innovative initiatives and recap on process optimizationSupport audit and inspection activities by maintaining proper documentationCollaborate effectively with team members and cross-functional partnersMentor junior case managersAdhere to data privacy and confidentiality requirementsMay collaborate in special projects as neededSpecialized 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 metTriage cases based on seriousness, expectedness, regulatory timelines, and medical vitalityRoute cases to appropriate processing queues or medical review pathwaysInitiate follow-up for invalid or incomplete case informationDocument receipt of information and complete intake forms/checklistsPerform literature screening and case identification from monitored publicationsProcess duplicate case assessments and case linking activitiesCoordinate with Medical Information, affiliates, and other case sources for information clarificationB. Case Processing Team:Enter complete case information from source documents into the safety databaseApply 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 indicationAssess case seriousness, expectedness, and causality (where applicable) according to defined criteriaWrite clear, concise, and scientifically accurate case narrativesPerform case assessments including clinical relevance and data consistency checksGenerate and follow-up queries for additional informationLink cases appropriately (duplicate, parent-child, case series)Process special case types including pregnancies, medication errors, off-label use, lack of efficacy, legalPerform in-line quality control checks prior to case finalizationPrepare cases for medical review ensuring all required elements are completeC. 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 agreementsGenerate investigator and ethics committee safety notifications for clinical trial casesPerform pre-submission quality checks ensuring accuracy and completenessSubmit reports through regulatory gateways and track transmission confirmationsProcess acknowledgments from health authorities and document successful submissionsGenerate nullifications and amendments for previously submitted reports when requiredMaintain reporting logs and ensure accurate documentation of all submissionsTroubleshoot gateway transmission failures and coordinate results.Understand and Support of the EU QPPV role   Understanding the roles and responsibilities of the EU Qualified Person.   Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities. Minimum Qualification Requirements:Bachelor’s degree or 10+ years experience. Healthcare degree, or study in the area of pharmaceutical/biological science.1+ years of Pharmacovigilance or related healthcare experience Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.Other Information/Additional Preferences:Masters Degree Highly conscientious with strong attention to detail.Demonstrated critical thinking and problem-solving skills.Ability to make decisions autonomously and as p