Case Manager- Case Management Operations

Eli Lilly and Company • Indianapolis, IN

1d

About The Position

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.

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 (depending on level)
• Highly conscientious with strong attention to detail.
• Demonstrated critical thinking and problem-solving skills.
• Ability to make decisions autonomously and as part of a team.
• Adaptability when using new or changing electronic systems.
• Highly organized with strong time management and prioritization skills.
• Basic digital literacy (i.e., word processing, tables and graphics, spreadsheets, presentations, templates, databases, and search engines).
• Ability to work effectively in a global capacity and apply understanding of diversity and inclusion.
• Strong written and verbal communication skills with fluency in writing, reading, and speaking English.
• Basic understanding of drug development and clinical research
• Familiarity with medical terminology
• Previous experience with safety databases (Argus, ARISg, Veeva, or similar)
• Knowledge of MedDRA and WHO-DD coding conventions
• Understanding of ICH guidelines and global PV regulations
• Experience in pharmaceutical industry, CRO, or healthcare setting

Nice To Haves

• Masters Degree
• Clinical background (RN, RPh, MLT, or equivalent) preferred for case processing roles
• Additional language capabilities beneficial for global case management

Responsibilities

• 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
• 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
• 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
• 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 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level