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Principal Pharmacovigilance Specialist

10+ years
Not Disclosed
10 Sept. 24, 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

Principal Pharmacovigilance Specialist

Location: India
Employment Type: Full-Time
Posted On: 6 Days Ago
Job Requisition ID: JR 7775


About ProPharma

For over 20 years, ProPharma has been committed to improving patient health and wellness by partnering with biotech, medical device, and pharmaceutical organizations of all sizes. Through an advise-build-operate model, ProPharma supports the entire product lifecycle, offering expertise in:

  • Regulatory Sciences

  • Clinical Research Solutions

  • Quality & Compliance

  • Pharmacovigilance

  • Medical Information

  • R&D Technology

Our goal is to de-risk and accelerate high-profile drug and device programs through fully customizable consulting solutions.


Essential Functions

As a Principal Pharmacovigilance Specialist, you will:

  • Act as a PV subject matter expert, providing oversight and client support.

  • Oversee development of Working Practices, Work Instructions, and PV Agreements.

  • Serve as a resource for Case Processing teams handling complex cases and escalated inquiries.

  • Conduct case follow-up activities (identifying and collecting missing information).

  • Create and review case narratives.

  • Provide client notifications as required for case management.

  • Support the development and delivery of training materials.

  • Highlight discrepancies or areas of concern related to ICSRs.

  • Maintain up-to-date knowledge of global safety regulations for medicines.

  • Perform peer reviews of cases for quality, consistency, and accuracy.

  • Conduct Health Care Professional (HCP) review, as required.

  • Mentor and train less experienced staff.

  • Carry out other duties as assigned.


Necessary Skills & Abilities

  • Strong verbal, written, and interpersonal communication skills (internal and external stakeholders).

  • Excellent project management skills.

  • High attention to detail and accuracy.

  • Advanced problem-solving abilities with timely resolution skills.

  • Ability to work independently and collaboratively in a multidisciplinary environment.

  • Strong organizational and prioritization skills.

  • Advanced knowledge of pharmacovigilance principles and regulations.

  • Proficiency in PV systems such as Oracle Argus Safety, ARISg, or other safety databases.

  • Self-motivated, efficient, and able to manage multiple projects and clients simultaneously.


Educational Requirements

  • Required: Bachelor’s degree in Life Sciences.

  • Preferred: Advanced degree (RN, RPh, PharmD, or equivalent).


Experience Requirements

  • Minimum 10 years of related work experience in pharmacovigilance.