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Qa Auditor – Pv

3-5 years
Not Disclosed
10 May 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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: QA Auditor – PV


Job Overview

We are currently seeking a QA Auditor – PV to join our growing team. This role is responsible for ensuring compliance with pharmacovigilance (PV) quality systems, conducting audits, and supporting regulatory and client inspections.


Key Responsibilities

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

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

  • Support in preparation and hosting of customer audits and PV regulatory inspections


Required Experience & Qualifications

  • 5+ years of experience in Global Pharmacovigilance (PV) System Management within pharmaceutical companies or PV service providers

  • 3+ years experience conducting GCP (Good Clinical Practice) and GVP (Good Pharmacovigilance Practice) audits

  • Proven experience in Corrective and Preventive Action (CAPA) management

  • Strong understanding of GVP guidelines

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