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Pharmacovigilance Specialist

2+ years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.