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Principal Pharmacovigilance Specialist

10+ years
Not Disclosed
10 Sept. 22, 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

Job Title:

Principal Pharmacovigilance Specialist

Company:

ProPharma Group

Job ID / Requisition:

JR 7775

Location:

India

Employment Type:

Full-time

Posted:

4 Days Ago


Company Overview:

ProPharma has over 20 years of experience supporting biotech, medical device, and pharmaceutical organizations. Operating across the full product lifecycle, ProPharma offers consulting solutions in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology, enabling clients to de-risk and accelerate high-profile drug and device programs.


Role Overview:

The Principal Pharmacovigilance (PV) Specialist serves as a subject matter expert in PV, providing oversight, guidance, and mentorship. The role supports both internal teams and clients, ensuring high-quality case processing, adherence to global safety regulations, and effective training and documentation practices.


Key Responsibilities:

Pharmacovigilance Oversight:

  • Provide PV subject matter expertise and guidance internally and to clients.

  • Oversee development of project-specific working practices, work instructions, and other documentation (e.g., Safety Data Exchange Agreements, PV Agreements).

  • Serve as a resource for the Case Processing team on complex cases and escalated inquiries.

  • Perform case follow-up activities, including identification of additional information needed.

  • Create and review case narratives.

  • Provide client notifications for case management as required.

Training & Mentorship:

  • Support development and delivery of training materials.

  • Mentor and train less experienced PV staff.

Quality & Compliance:

  • Peer review cases for quality, consistency, and accuracy.

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

  • Highlight discrepancies or areas of concern to the Principal PV Specialist, Case Processing, or Manager, Case Processing.

  • Maintain up-to-date knowledge of global PV regulations and standards.

Other Duties:

  • Perform additional tasks as assigned to support PV operations and client services.


Required Skills & Competencies:

  • Strong verbal, written, and interpersonal communication skills.

  • Excellent project management skills.

  • High accuracy and attention to detail.

  • Advanced problem-solving and decision-making abilities.

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

  • Excellent organizational and prioritization skills.

  • Advanced knowledge of pharmacovigilance and PV systems (e.g., Oracle Argus Safety, ARISg).

  • Self-motivated, efficient, and capable of managing multiple projects and clients.


Education Requirements:

  • Required: Bachelor’s degree in Life Sciences.

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


Experience Requirements:

  • Minimum 10 years of relevant work experience in pharmacovigilance or related fields.


Diversity & Inclusion Statement:

ProPharma values diversity, equity, and inclusion, fostering an environment where employees can be their authentic selves. The company encourages innovation, collaboration, and entrepreneurial thinking while providing a safe and empowering workspace.


Note:

ProPharma does not accept unsolicited resumes from recruiters or third parties. Please do not contact employees regarding this posting.