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 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.
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
- Onsite IndianapolisIN, (3 days on site/2 remote)
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 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 optimally 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
- Clinical background (RN, RPh, MLT, or equivalent) preferred for case processing roles
- 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
- Additional language capabilities beneficial for global case management
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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
$65,250 - $148,500
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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