ProPharma Group Hiring Pharmacovigilance Specialist – Case Processing

PROPHARMA GROUP INDIA PRIVATE LIMITED; Bengaluru; On-site; INR 600,000 - 1,000,000; Full time

Job summary

ProPharma Bangalore is seeking a Pharmacovigilance Specialist – Case Processing to manage ICSRs, code events with MedDRA, and draft safety narratives. You will ensure timely regulatory submissions and maintain high safety standards across global projects.

The role requires a life sciences degree with at least 2 years in PV or drug safety, strong writing skills, and the ability to work independently in a cross-functional team environment at our Bangalore office.

Qualifications

• Bachelor’s degree in Life Sciences (Pharmacy, Biotechnology, Biochemistry, Microbiology, Nursing, or related fields).
• Minimum 2 years of pharmacovigilance or drug safety experience (case processing preferred).
• Strong knowledge of pharmacovigilance principles and ICSR processing.
• Familiarity with MedDRA, WHO-DD, and global safety regulations.
• Excellent communication and medical writing skills.
• High attention to detail, problem-solving, and multitasking abilities.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Manage individual case safety reports (ICSRs) with accuracy and compliance.
• Perform initial assessment of seriousness, expectedness, and causality.
• Code adverse events using MedDRA terminology.
• Compose accurate medical narratives for safety cases.
• Generate queries for missing or unclear data.
• Ensure expedited reporting to global health authorities per regulatory guidelines.
• Prepare and review regulatory safety submissions, SOPs, and working practices.
• Conduct case follow-ups, narrative reviews, and peer quality checks.
• Provide client notifications and safety updates as needed.
• Contribute to training and mentoring within the pharmacovigilance team.
• Maintain up-to-date knowledge of international drug safety regulations.

Skills

ICSR processing

MedDRA terminology

Pharmacovigilance

Medical writing

Regulatory knowledge

Communication

Attention to detail

Teamwork

Education

Bachelor's in Life Sciences

Advanced degree (MSc/Pharm.D/RPh)

Job description

Pharmacovigilance Specialist Openings | ProPharma Bangalore

ProPharma, a leading global provider of consulting solutions across the biotech, pharmaceutical, and medical device industry, is inviting applications for the role of Pharmacovigilance Specialist – Case Processing at its Bangalore location. This is an excellent opportunity for life sciences professionals seeking to build a strong career in pharmacovigilance, drug safety, and regulatory compliance.

For over 20 years, ProPharma has been helping healthcare innovators bring therapies to market safely by offering end-to-end services including regulatory sciences, clinical research, pharmacovigilance, medical information, and R&D technology. With a client base that spans from startups to Fortune 500 companies, ProPharma is recognized as a trusted global partner in healthcare advancement.

Company Overview

ProPharma is a trusted name in pharma consulting and drug safety solutions, with a mission to improve patient health and wellness worldwide. The company operates on an advise-build-operate model across the full product lifecycle, ensuring clients can confidently bring scientific breakthroughs and therapies to market. Its expertise lies in compliance, clinical operations, pharmacovigilance, and regulatory sciences, backed by a team of highly experienced professionals.

Job Role & Responsibilities

As a Pharmacovigilance Specialist – Case Processing, you will:

• Manage individual case safety reports (ICSRs) with accuracy and compliance.
• Perform initial assessment of seriousness, expectedness, and causality.
• Code adverse events using MedDRA terminology.
• Compose accurate medical narratives for safety cases.
• Generate queries for missing or unclear data.
• Ensure expedited reporting to global health authorities per regulatory guidelines.
• Prepare and review regulatory safety submissions, SOPs, and working practices.
• Conduct case follow-ups, narrative reviews, and peer quality checks.
• Provide client notifications and safety updates as needed.
• Contribute to training and mentoring within the pharmacovigilance team.
• Maintain up-to-date knowledge of international drug safety regulations.

Eligibility / Qualifications

• Required Education: Bachelor’s degree in Life Sciences (Pharmacy, Biotechnology, Biochemistry, Microbiology, Nursing, or related fields).
• Preferred Education: Advanced degree such as MSc, Pharm.D, RPh, RN, or equivalent.
• Experience: Minimum 2 years of pharmacovigilance or drug safety experience (case processing preferred).
• Key Skills:
  • Strong knowledge of pharmacovigilance principles and ICSR processing.
  • Familiarity with MedDRA, WHO-DD, and global safety regulations.
  • Excellent communication and medical writing skills.
  • High attention to detail, problem-solving, and multitasking abilities.
  • Ability to work independently and in cross-functional teams.

Location & Salary

• Location: Bangalore, India
• Salary: Competitive package aligned with experience and industry standards.

Why Join ProPharma?

• Opportunity to work with a globally recognized leader in drug safety and pharmacovigilance.
• Exposure to diverse projects across biotech, medical devices, and pharmaceuticals.
• Career advancement through training, mentoring, and international exposure.
• Inclusive and diverse workplace culture that values innovation and collaboration.
• Chance to contribute to global patient safety and healthcare advancements.

Frequently Asked Questions (FAQs)

Q1: What qualifications are required for this role?
A Bachelor’s degree in Life Sciences is mandatory. Advanced qualifications like Pharm.D, MSc, or RPh are preferred.

Q2: How much experience is required?
At least 2 years of pharmacovigilance or case processing experience is required.

Q3: What are the key responsibilities of a PV Specialist?
The role involves handling ICSRs, coding with MedDRA, writing narratives, regulatory submissions, and client safety communications.

Q4: Where is this position located?
This role is based at ProPharma’s Bangalore office.

Q5: How can I apply?
You can apply directly via ProPharma’s official careers page using the provided application link.