At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
The Case Manager, Case Management Operations is responsible for the accurate, timely, and 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.
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
- Utilize safety database systems (e.g., Argus, Veeva) effectively for assigned tasks
Maintain high quality standards with attention to detail and accuracy
- Escalate complex cases, questions, or issues to management appropriately
- Participate in training programs and maintain competency in assigned functional areas
- Contribute to continuous improvement initiatives and provide feedback 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 participate in special projects as needed
A. 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 urgency
- 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
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 track 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
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 accurate documentation of all submissions
- Troubleshoot gateway transmission failures and coordinate resolution
3. 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 requireements:
Bachelor’s degree, master's degree or equivalent experience. Healthcare degree, or study in the area of pharmaceutical/biological science.
3-8 years of Pharmacovigilance or related healthcare experience
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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