Analyst – Pharmacovigilance (PV)
Company: Elanco
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: Global Pharmacovigilance (GPV)
Experience: 0–2 Years
About the Role
Elanco is seeking an Analyst – Pharmacovigilance (PV) to support global pharmacovigilance operations through adverse event case processing, safety data management, regulatory reporting, and compliance activities. The role offers an excellent opportunity for candidates looking to build a career in drug safety and pharmacovigilance within a global animal health organization.
Key Responsibilities
Adverse Event Case Processing
Perform adverse event case processing activities within the PV database.
Conduct data entry, seriousness assessment, and causality assessment of adverse event reports.
Validate safety information against source documents and supporting records.
Ensure case completeness, accuracy, and quality before submission.
Identify missing information and initiate follow-up activities when required.
Meet established productivity and quality standards.
Pharmacovigilance Operations
Assess adverse event reports for reportability and regulatory requirements.
Support timely processing and submission of safety cases.
Maintain compliance with internal SOPs and global pharmacovigilance regulations.
Participate actively in team discussions and operational activities.
Global PV Support
Support global pharmacovigilance activities and safety operations.
Monitor and manage global adverse event mailboxes.
Assist with individual case safety report (ICSR) submissions.
Stay updated on global pharmacovigilance regulations and industry requirements.
Stakeholder Collaboration
Collaborate with affiliate offices, customer response teams, call centers, legal teams, and internal stakeholders.
Communicate safety-related information effectively and professionally.
Maintain confidentiality and ensure compliance with company data protection requirements.
Required Qualifications
Education
Bachelor's or Master's Degree in:
Pharmacy
Life Sciences
Biotechnology
Microbiology
Veterinary Sciences
Related Healthcare Discipline
Experience
0–2 years of experience in Pharmacovigilance or Drug Safety.
Freshers with relevant educational background may also be considered.
Prior experience in adverse event case processing is preferred.
Required Skills
Pharmacovigilance (PV)
Adverse Event Case Processing
Drug Safety
Seriousness Assessment
Causality Assessment
Medical Terminology
Safety Database Management
Regulatory Compliance
Case Documentation
Data Entry & Quality Review
Communication Skills
Attention to Detail
Team Collaboration
Preferred Qualifications
Exposure to Pharmacovigilance case processing.
Understanding of global PV regulations and reporting requirements.
Knowledge of Individual Case Safety Reports (ICSRs).
Experience with safety databases is an advantage.
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