Pharmacovigilance Specialist – Case Processing
Location: India
Job Type: Full-Time, Regular
Experience Required: Fresher – 2+ years
About ProPharma
For over 20 years, ProPharma Group has been at the forefront of advancing patient health and safety by providing expert guidance to biotechnology, medical device, and pharmaceutical organizations worldwide. Operating across the entire product lifecycle, we deliver tailored solutions in regulatory sciences, clinical research, pharmacovigilance, quality & compliance, medical information, and R&D technology, enabling clients to accelerate drug development and ensure regulatory compliance.
Role Overview
The Pharmacovigilance (PV) Specialist – Case Processing plays a critical role in managing individual case safety reports (ICSRs), performing initial case assessments, coding adverse events, drafting medical narratives, and ensuring regulatory reporting compliance. The PV Specialist ensures quality, consistency, and timely submission of safety information while supporting training and continuous process improvement initiatives.
This position is ideal for freshers or candidates with limited experience in pharmacovigilance, offering exposure to global PV practices and end-to-end case management processes.
Key Responsibilities
Process adverse event cases from clinical trials and post-marketing sources.
Perform case-level assessment including seriousness, expectedness, and follow-up information.
Accurately code adverse events using MedDRA and other relevant dictionaries.
Draft and review medical narratives for ICSRs.
Ensure timely reporting of cases to regulatory authorities per SOPs, working practices, and global safety regulations.
Conduct peer reviews to ensure case quality, accuracy, and consistency.
Assist in training material development and delivery for case processing teams.
Identify potential discrepancies or safety concerns and escalate to Principal PV Specialists or Managers.
Stay current on global pharmacovigilance regulations, guidelines, and industry best practices.
Required Skills & Competencies
Strong verbal and written communication skills in English.
High attention to detail, accuracy, and analytical thinking.
Ability to work independently as well as collaboratively in cross-functional teams.
Effective organizational and multitasking skills with the ability to prioritize tasks.
Basic understanding of pharmacovigilance principles and regulatory requirements.
Commitment to quality, compliance, and continuous improvement.
Educational Requirements
Required: Bachelor’s degree in Life Sciences.
Preferred: Advanced degree (MSc, RN, RPh, PharmD, or equivalent).
Experience
Freshers are welcome to apply. Previous internships or exposure to pharmacovigilance or clinical operations is a plus.
Up to 2 years of related work experience can be considered.
Why Join ProPharma
Work in a global, collaborative, and inclusive environment.
Gain exposure to end-to-end pharmacovigilance operations and case management.
Develop expertise in regulatory compliance, global safety reporting, and medical coding.
Be part of a team that values innovation, continuous learning, and career growth.
Commitment to Diversity & Inclusion
ProPharma is an Equal Opportunity Employer, committed to creating a safe, inclusive, and empowering workplace. We celebrate diversity and encourage employees to bring their authentic selves to work.
Apply Now
Join ProPharma to build a career in pharmacovigilance, contribute to patient safety, and gain valuable experience in global clinical safety and regulatory compliance.
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