Job Title: Pharmacovigilance Specialist
Job Type: Full-Time
Location: India
Job Requisition ID: JR 8350
Posted: 18 Days Ago
About the Company
ProPharma is a global organization with over 20 years of experience supporting biotech, pharmaceutical, and medical device companies in advancing scientific breakthroughs and launching new therapies. ProPharma provides end-to-end services across:
Regulatory Sciences
Clinical Research
Pharmacovigilance
Medical Information
Quality & Compliance
R&D Technology
The company works under an advise → build → operate model to successfully manage products throughout their lifecycle.
Role Overview
The Pharmacovigilance (PV) Specialist, Case Processing is responsible for managing Individual Case Safety Reports (ICSRs). The role involves case evaluation, medical narrative preparation, regulatory submission, and ensuring compliance with global safety regulations and internal SOPs.
Key Responsibilities
Perform daily case processing for both clinical trial and post-marketed safety reports.
Code adverse events using MedDRA.
Determine seriousness and expectedness at both event and case level.
Create, review, and finalize medical case narratives.
Identify missing information and perform case follow-up activities.
Notify clients and stakeholders as required during case management.
Conduct peer review of processed cases for accuracy and consistency.
Maintain up-to-date knowledge of global drug safety regulations.
Support and contribute to training materials and training sessions.
Report discrepancies or concerns to senior PV team members.
Perform additional tasks as assigned.
Required Skills & Competencies
Strong verbal and written communication skills.
High attention to detail and accuracy.
Ability to analyze and resolve issues effectively.
Capable of working both independently and collaboratively.
Strong time management and organizational skills.
Ability to multi-task and prioritize workload.
Basic understanding of Pharmacovigilance concepts.
Educational Qualifications
Required: Bachelor’s degree in Life Sciences.
Preferred: Advanced degree (e.g., RN, RPh, PharmD) or equivalent.
Experience Requirements
Minimum: 2 years of relevant Pharmacovigilance or Case Processing experience.
Equal Opportunity Commitment
ProPharma promotes diversity, equity, and inclusion, ensuring a workplace where every employee can work as their authentic self. The organization values collaboration, innovation, and professional growth.
Application Note
All applications are personally evaluated by the recruitment team (no AI screening). Every applicant receives a response—selected or not.
Third-party recruiter submissions are not accepted.
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