Job Title: Senior Pharmacovigilance Specialist
Company: ProPharma
Location: India (Hybrid / Remote)
Job Type: Full-Time
Experience Required: 3+ Years
Qualification: Bachelor’s in Life Sciences (Advanced degree / PharmD preferred)
Job Overview
Senior Pharmacovigilance Specialist responsible for end-to-end adverse event (ICSR) case processing, quality review, and pharmacovigilance oversight. The role ensures compliance with global drug safety regulations and supports training, mentoring, and case quality improvement activities.
Key Responsibilities
ICSR Case Processing & Review
Process adverse event cases from clinical trials and post-marketing sources
Perform MedDRA coding for medical terms and adverse events
Assess seriousness, expectedness, and case validity
Conduct case follow-ups and collect additional safety information
Quality & Compliance
Perform peer review of cases for accuracy and consistency
Identify discrepancies and escalate to senior PV leadership
Ensure compliance with global PV regulations and SOPs
Maintain up-to-date knowledge of safety regulations
Narratives & Documentation
Draft and review case narratives
Ensure proper documentation of all safety case activities
Support regulatory reporting requirements
Stakeholder & Communication
Provide client notifications for case management updates
Coordinate with medical reviewers and PV teams
Support audits and inspection readiness
Training & Mentoring
Assist in development of training materials
Mentor junior PV associates and analysts
Support knowledge sharing across teams
Required Skills
Pharmacovigilance Case Processing (ICSR)
MedDRA Coding
Drug Safety Surveillance
Case Narrative Writing
Regulatory Compliance (GVP, ICH)
Oracle Argus Safety / ArisG / PV Systems
Quality Review & Peer Review
Problem Solving & Case Assessment
Strong Communication Skills
Attention to Detail
Time & Priority Management
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