Analyst – Pharmacovigilance (PV)
Location: Bangalore, India
Company: Elanco
Department: Global Pharmacovigilance (GPV)
Employment Type: Full-Time
Role Summary
The Analyst – Pharmacovigilance (PV) is responsible for supporting global pharmacovigilance operations through adverse event case processing, safety data management, regulatory submissions, and pharmacovigilance compliance activities. The role ensures timely and accurate processing of safety reports while maintaining compliance with global pharmacovigilance regulations and internal quality standards.
This position provides an excellent opportunity for early-career pharmacovigilance professionals to develop expertise in drug safety surveillance, case processing, regulatory reporting, and global PV operations.
Key Responsibilities
Adverse Event Case Processing
Perform end-to-end processing of adverse event (AE) reports.
Enter and validate safety data within pharmacovigilance databases.
Assess:
Case Seriousness
Reportability
Causality
Completeness of Safety Information
Review source documents and call notes for accuracy.
Ensure cases are complete, accurate, and submission-ready.
Identify missing information and determine follow-up requirements.
Conduct self-quality review before case finalization.
Meet established productivity, quality, and compliance targets.
Safety Data Management
Maintain accurate safety records and case documentation.
Ensure data integrity throughout the case lifecycle.
Support ongoing maintenance of pharmacovigilance databases.
Track and manage safety information according to company procedures.
Regulatory Reporting & Compliance
Support submission of Individual Case Safety Reports (ICSRs) to regulatory authorities.
Ensure compliance with internal and external reporting timelines.
Adhere to global pharmacovigilance regulations and company SOPs.
Maintain awareness of evolving pharmacovigilance requirements.
Global Pharmacovigilance Support
Support global GPV operational activities.
Monitor and manage global adverse event mailboxes.
Assist with pharmacovigilance-related projects and initiatives.
Stay current on global drug safety regulations and practices.
Cross-Functional Collaboration
Collaborate with:
Global Pharmacovigilance Teams
Affiliate Offices
Call Centers
Customer Response Teams
Legal Teams
Regulatory Affairs Teams
Communicate case-related issues and escalate concerns appropriately.
Participate actively in team discussions and meetings.
Confidentiality & Compliance
Handle confidential safety and company information responsibly.
Ensure compliance with data privacy and confidentiality requirements.
Follow applicable company policies and regulatory obligations.
Verify appropriate confidentiality agreements when required.
Required Qualifications
Education
Bachelor’s Degree or Master’s Degree in:
Pharmacy
Life Sciences
Biotechnology
Pharmacology
Nursing
Veterinary Sciences
Related Healthcare Discipline
Experience
0–2 years of experience in:
Pharmacovigilance
Drug Safety
Clinical Research
Healthcare Operations
Preferred Experience
Experience in:
PV Case Processing
ICSR Management
Literature Review
Safety Database Operations
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Remote, India | Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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