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Qa Auditor – Pv

5+ years
Not Disclosed
10 Sept. 18, 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

QA Auditor – Pharmacovigilance (PV)

Job Overview

We are seeking a QA Auditor – PV to ensure the effectiveness and compliance of pharmacovigilance systems, processes, and vendor activities. The role involves conducting audits, maintaining quality metrics, and supporting customer audits and PV inspections.


Key Responsibilities

  • Implement and maintain the pharmacovigilance system, quality processes, and performance metrics.

  • Conduct audits of projects, systems, processes, and vendors as assigned.

  • Support preparation for customer audits and PV inspections.

  • Identify process gaps and contribute to corrective and preventive action (CAPA) plans.


Required Qualifications & Experience

  • Experience:

    • 5+ years in Global PV System Management within pharmaceutical companies or PV service providers.

    • 3+ years conducting GCP and GVP audits.

    • 3+ years managing PV Quality Management Systems (QMS).

  • Knowledge & Skills:

    • Strong understanding of PV principles and practices.

    • In-depth knowledge of GVP guidelines.

    • Experience in CAPA management.


Why Join

  • Contribute to the maintenance and improvement of global pharmacovigilance systems.

  • Participate in high-impact audits and inspections supporting patient safety and regulatory compliance.

  • Work within a structured, quality-driven environment with professional growth opportunities.