Analyst – Pharmacovigilance (PV)
Company: Elanco
Location: Bangalore, India
Department: Global Pharmacovigilance (GPV) / Drug Safety
Employment Type: Full-Time
Role Summary
The Analyst – Pharmacovigilance (PV) is responsible for processing adverse event reports, performing case assessments, supporting global pharmacovigilance operations, and ensuring regulatory compliance for animal health products. The role involves adverse event case processing, seriousness and causality assessment, regulatory submissions, safety database management, and collaboration with global pharmacovigilance teams to ensure timely and accurate safety reporting.
Key Responsibilities
Adverse Event Case Processing
Perform data entry of adverse event reports into PV databases.
Conduct:
Seriousness Assessment
Causality Assessment
Reportability Assessment
Case Validation
Review source documents and call notes for accuracy.
Perform self-quality checks for completeness and correctness.
Ensure cases are submission-ready within regulatory timelines.
Identify and escalate case processing issues and delays.
Pharmacovigilance Operations
Process:
Adverse Event Reports
Product Complaint Cases
Safety Reports
Determine follow-up information requirements.
Ensure compliance with pharmacovigilance regulations and internal procedures.
Maintain productivity and quality standards.
Global GPV Support
Support global pharmacovigilance activities.
Monitor updates in global drug safety regulations.
Assist internal stakeholders on GPV-related activities.
Manage global adverse event mailbox activities.
Perform regulatory submissions of Individual Case Safety Reports (ICSRs).
Regulatory Compliance
Ensure compliance with:
Global Pharmacovigilance Requirements
Regulatory Reporting Timelines
Internal SOPs
Drug Safety Guidelines
Support inspection readiness and compliance activities.
Stakeholder Collaboration
Coordinate with:
Affiliate Offices
Call Centers
Legal Teams
Customer Response Teams
Pharmacovigilance Colleagues
Communicate safety information effectively.
Maintain confidentiality of company and safety data.
Quality & Documentation
Ensure high-quality case documentation.
Maintain accurate safety records.
Participate in team meetings and process improvement activities.
Support continuous learning in pharmacovigilance regulations.
Required Qualifications
Education
Bachelor’s Degree in:
Pharmacy
Life Sciences
Veterinary Sciences
Biotechnology
Clinical Research
Related Healthcare Discipline
Experience
0–2 years of experience in:
Pharmacovigilance
Drug Safety
ICSR Processing
Clinical Safety Operations
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