Associate – Clinical Case Management
Location: Bengaluru, India
Company: Eli Lilly
Department: Pharmacovigilance / Clinical Safety & Case Management
Employment Type: Full-Time
Role Summary
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 supports global pharmacovigilance operations through case intake, triage, data entry, medical coding, narrative writing, regulatory reporting, and safety submissions while ensuring compliance with global PV regulations and company procedures.
The position works within Case Management Operations and may support Intake & Triage, Case Processing, or Reporting & Submissions functions.
Key Responsibilities
ICSR Case Management
Process Individual Case Safety Reports (ICSRs) within required timelines.
Ensure data accuracy, quality, consistency, and compliance.
Perform peer review and quality review of safety cases.
Maintain complete documentation within safety databases.
Support audit and inspection readiness activities.
Case Intake & Triage
Receive adverse event reports from:
Spontaneous Reports
Clinical Trials
Literature Sources
Digital Media
Healthcare Professionals
Validate cases against minimum reporting criteria.
Assess seriousness, expectedness, and reporting timelines.
Route cases to appropriate review and processing teams.
Initiate follow-up requests for missing information.
Perform duplicate detection and case linking activities.
Conduct literature screening and case identification.
Case Processing
Enter safety data into safety databases.
Perform:
MedDRA Coding
WHO-DD Coding
Seriousness Assessment
Causality Assessment
Expectedness Assessment
Prepare scientifically accurate case narratives.
Review clinical relevance and data consistency.
Generate and manage follow-up queries.
Process:
Pregnancy Cases
Medication Errors
Off-label Use Cases
Lack of Efficacy Cases
Special Safety Events
Perform quality checks before case finalization.
Regulatory Reporting & Safety Submissions
Generate expedited safety reports (7-Day & 15-Day Reporting).
Prepare:
E2B Submissions
CIOMS Reports
Local Regulatory Reports
Submit reports to:
Regulatory Authorities
Ethics Committees
Investigators
Business Partners
Track submission acknowledgements and confirmations.
Manage amendments, follow-ups, and nullification reports.
Resolve submission gateway issues.
Pharmacovigilance Compliance
Follow:
Global PV Regulations
SOPs
Work Instructions
Data Privacy Requirements
Support inspection and audit activities.
Participate in process improvement initiatives.
Ensure compliance with pharmacovigilance agreements.
Stakeholder Collaboration
Collaborate with:
Medical Information Teams
Regulatory Affairs
Global Safety Teams
Affiliates
Healthcare Professionals
Mentor junior case managers when required.
Support cross-functional safety activities.
EU QPPV Support
Understand EU QPPV responsibilities.
Support activities enabling QPPV compliance.
Assist in maintaining EU Pharmacovigilance System requirements.
Required Qualifications
Education
Bachelor’s Degree or Master’s Degree in:
Pharmacy
Life Sciences
Biotechnology
Biochemistry
Microbiology
Medical Sciences
Biological Sciences
Healthcare Sciences
Experience
3–8 years of experience in:
Pharmacovigilance
Drug Safety
Clinical Safety
ICSR Case Processing
Safety Reporting
Regulatory Submissions
Healthcare Operations
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
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Gottingen | Hannover | Leipzig |Saxony Anhalt :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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