Pharmacovigilance Specialist
Location: India
Job Type: Full-time
Job Requisition ID: JR 8350
Posted: 21 Days Ago
Company: ProPharma
About ProPharma
For 20+ years, ProPharma has supported biotech, medical device, and pharmaceutical companies across the full product lifecycle. Through an advise–build–operate model, they provide expertise in:
Regulatory Sciences
Clinical Research
Quality & Compliance
Pharmacovigilance
Medical Information
R&D Technology
They specialize in helping partners accelerate drug/device programs with high-quality, customizable solutions.
Role Overview
The Pharmacovigilance (PV) Specialist, Case Processing is responsible for managing Individual Case Safety Reports (ICSRs), assessing safety data, composing medical narratives, and ensuring cases are processed and submitted in compliance with global regulatory requirements. The role focuses on accuracy, timelines, and quality while delivering an excellent internal and external customer experience.
Key Responsibilities
1. Case Processing
Perform daily processing of AE cases (clinical trial & post-marketing).
Code adverse events using MedDRA.
Determine seriousness, expectedness, and causality at event/case level.
2. Follow-up Management
Identify required follow-up information.
Generate and track follow-up queries.
3. Case Documentation
Draft and review medical narratives.
Ensure completeness, clarity, and regulatory compliance.
4. Communication & Notifications
Provide client updates regarding case status and management.
5. Quality, Review & Compliance
Perform peer reviews for quality, consistency, and accuracy.
Escalate discrepancies or concerns to Principal PV Specialist / Manager.
Ensure adherence to:
Internal guidelines
SOPs & Working Practices
Applicable global safety regulations
6. Training & Knowledge Management
Support development and delivery of training materials.
Maintain updated knowledge of global PV regulations.
7. Additional Responsibilities
Support team operations as required.
Perform any other assigned tasks to enhance service quality.
Required Skills & Abilities
Strong verbal, written, and interpersonal communication.
High attention to detail and accuracy.
Problem-solving ability with timely decision-making.
Ability to work independently and in cross-functional teams.
Excellent organization, prioritization, and multitasking skills.
Basic understanding of Pharmacovigilance processes.
Education Requirements
Required: Bachelor’s degree in Life Sciences.
Preferred: Advanced degree (RN, RPh, PharmD, etc.).
Experience Requirements
Minimum: 2 years of relevant experience in pharmacovigilance or related field.
Company Values
Commitment to diversity, equity, and inclusion.
Culture supports innovation, collaboration, and authenticity.
All applications are reviewed manually by recruiters, not AI tools.
Applicants always receive communication regarding application outcome.
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