Associate – Clinical Case Management
Company: Eli Lilly
Location: Bengaluru, India
Department: Pharmacovigilance / Case Management Operations
Job Type: Full-Time
Experience: 3–8 Years
JOB OVERVIEW
The Associate – Clinical Case Management is responsible for the accurate, timely, and compliant processing of Individual Case Safety Reports (ICSRs) for Lilly products and compounds. The role involves adverse event intake, case triage, data entry, MedDRA and WHO-DD coding, narrative writing, case assessment, follow-up, regulatory reporting, and safety submissions while ensuring compliance with global pharmacovigilance regulations, company SOPs, and data quality standards.
KEY RESPONSIBILITIES
ICSR Case Management
Process Individual Case Safety Reports (ICSRs).
Perform end-to-end case processing.
Ensure timely case completion.
Maintain case quality and accuracy.
Perform peer review of safety cases.
Conduct aggregate case reviews.
Escalate complex safety cases.
Case Intake & Triage
Receive adverse event reports from multiple sources.
Perform initial case validity assessment.
Verify minimum criteria for valid ICSRs.
Prioritize cases based on regulatory timelines.
Route cases to appropriate processing teams.
Initiate follow-up for incomplete reports.
Perform duplicate case detection.
Conduct literature screening.
Coordinate with Medical Information teams.
Case Processing
Enter case data into the safety database.
Perform MedDRA coding.
Perform WHO Drug Dictionary (WHO-DD) coding.
Assess seriousness.
Assess expectedness.
Assess causality where applicable.
Prepare scientifically accurate narratives.
Perform clinical relevance assessment.
Generate follow-up queries.
Link duplicate and related cases.
Process pregnancy cases.
Process medication error cases.
Process off-label use cases.
Process lack of efficacy cases.
Process legal cases.
Perform in-line quality control.
Prepare cases for medical review.
Regulatory Reporting
Generate expedited safety reports.
Prepare E2B submissions.
Prepare CIOMS reports.
Submit reports to health authorities.
Submit reports to business partners.
Generate investigator notifications.
Generate ethics committee notifications.
Perform pre-submission quality checks.
Track submission acknowledgements.
Process report amendments.
Process report nullifications.
Maintain reporting logs.
Resolve gateway transmission issues.
Quality & Compliance
Follow global pharmacovigilance regulations.
Follow company SOPs and work instructions.
Maintain inspection-ready documentation.
Support audits and inspections.
Ensure data integrity.
Maintain patient confidentiality.
Ensure regulatory compliance.
Participate in continuous improvement initiatives.
Safety Systems
Work with Oracle Argus Safety.
Work with Veeva Safety.
Maintain safety databases.
Ensure accurate safety data management.
Collaboration & Leadership
Collaborate with cross-functional teams.
Mentor junior Case Managers.
Support Group Leaders.
Participate in training programs.
Support EU QPPV responsibilities.
Contribute to process optimization initiatives.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree
Master's Degree
Pharmacy
Life Sciences
Biological Sciences
Healthcare Sciences
Pharmaceutical Sciences
Equivalent healthcare qualification
EXPERIENCE REQUIREMENTS
Required
3–8 years of Pharmacovigilance experience
Experience in ICSR Case Processing
Experience with global safety reporting
Experience using safety databases
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