Global pharmaceutical company Eli Lilly and Company is hiring an Associate โ Clinical Case Management in Bengaluru, India. This pharmacovigilance job opportunity is ideal for professionals with 3-8 years of experience in Individual Case Safety Report (ICSR) processing, case management operations, MedDRA coding, WHO-DD coding, and regulatory reporting.
The role offers an opportunity to work on global drug safety activities, ensuring compliance with international pharmacovigilance regulations while contributing to patient safety and regulatory excellence.
About Eli Lilly
Eli Lilly and Company is a leading global pharmaceutical organization headquartered in Indianapolis, Indiana, USA. With more than 50,000 employees worldwide, Lilly focuses on discovering and delivering life-changing medicines while improving healthcare outcomes and advancing scientific innovation.
Job Title
Associate โ Clinical Case Management
Job Location
Bengaluru, Karnataka, India
Application Deadline
June 29, 2026
Key Responsibilities
ICSR Processing and Case Management
- Process Individual Case Safety Reports (ICSRs) accurately within defined timelines.
- Maintain data integrity and compliance with global pharmacovigilance regulations.
- Utilize safety databases including Argus and Veeva.
- Conduct quality reviews and ensure documentation accuracy.
- Support audits, inspections, and continuous process improvement initiatives.
Intake and Triage Activities
- Receive and acknowledge adverse event reports from multiple sources.
- Determine minimum criteria for valid ICSRs.
- Prioritize cases based on seriousness and regulatory requirements.
- Initiate follow-up for incomplete information.
- Conduct literature screening and duplicate case assessments.
- Coordinate with medical information teams and affiliates.
Case Processing Activities
- Enter case information into safety databases.
- Perform MedDRA coding using appropriate LLTs and PTs.
- Apply WHO Drug Dictionary coding for medicinal products.
- Assess seriousness, expectedness, and causality.
- Prepare scientifically accurate case narratives.
- Process pregnancy cases, medication errors, off-label use, and lack of efficacy cases.
- Conduct quality checks before medical review.
Reporting and Regulatory Submissions
- Generate expedited reports according to 7-day and 15-day reporting timelines.
- Prepare E2B, CIOMS, and local safety submissions.
- Submit reports to regulatory authorities and business partners.
- Track acknowledgments and manage amendments or nullifications.
- Resolve gateway transmission issues and maintain submission logs.
EU QPPV Support
- Understand the responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV).
- Support activities enabling compliance with legal pharmacovigilance requirements.
Eligibility Criteria
Educational Qualification
Candidates should possess:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc (Life Sciences)
- M.Sc (Life Sciences)
- Biotechnology
- Microbiology
- Biological Sciences
- Pharmacy or Healthcare-related Degree
- Equivalent qualification in pharmaceutical or biological sciences
Experience Required
- 3 to 8 years of Pharmacovigilance or related healthcare experience.
- Experience in ICSR case processing and regulatory reporting is preferred.
- Working knowledge of Argus Safety Database and Veeva is desirable.
Required Skills
- Pharmacovigilance Operations
- Individual Case Safety Report (ICSR) Processing
- MedDRA Coding
- WHO-DD Coding
- Narrative Writing
- Safety Database Management
- Argus Safety
- Veeva Vault Safety
- E2B Reporting
- CIOMS Reporting
- Case Assessment and Follow-up
- Regulatory Compliance
- Attention to Detail
- Data Quality Management
- Cross-functional Collaboration
Why Join Eli Lilly?
- Opportunity to work with a globally recognized pharmaceutical company.
- Exposure to international pharmacovigilance operations.
- Experience with advanced safety systems and regulatory processes.
- Collaborative and inclusive work environment.
- Career growth opportunities in global drug safety and case management.
- Meaningful work contributing to patient safety worldwide.
How to Apply
