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Qa Auditor – Pv

3-5 years
Not Disclosed
10 June 24, 2025
Job Description
Job Type: Full Time Hybrid 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

 

QA Auditor – PV (Pharmacovigilance Quality Assurance)

Job Summary:

A leading pharmaceutical organization is seeking a skilled QA Auditor – PV to oversee and maintain the pharmacovigilance (PV) system, ensure quality processes, and conduct comprehensive audits. The role is ideal for professionals with 5+ years of PV system management experience and at least 3 years in GCP/GVP auditing within pharmaceutical companies or PV service providers.


Key Responsibilities:

  • Implement and maintain the pharmacovigilance system, ensuring compliance with global standards.

  • Develop, monitor, and improve quality processes and PV system metrics.

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

  • Support internal teams in preparation for customer audits and PV inspections.

  • Review CAPA (Corrective and Preventive Actions) and ensure timely and effective resolution.


Required Skills & Qualifications:

  • 5+ years of experience in global PV system management in pharmaceutical firms or PV service providers.

  • 3+ years of hands-on experience conducting GCP and GVP audits.

  • Proven expertise in CAPA management within pharmacovigilance operations.

  • Strong knowledge of Good Pharmacovigilance Practices (GVP) guidelines and regulatory requirements.

  • Minimum 3 years of experience managing PV Quality Management Systems.

  • Excellent communication and organizational skills.

  • Ability to work cross-functionally and lead PV quality improvement initiatives.


Perks & Benefits:

  • Opportunity to lead and shape PV Quality Systems in a global setting.

  • Exposure to global regulatory audits and inspections.

  • Professional development and skill enhancement programs.

  • Competitive compensation package (Not specified in JD).

  • Collaborative and supportive team environment.


Company Description:

A globally recognized pharmaceutical company committed to drug safety, quality assurance, and regulatory excellence. The organization specializes in pharmacovigilance, ensuring patient safety and compliance with international healthcare standards.


Work Mode:

On-site / Hybrid (Location not specified in JD)


Call to Action:

Are you an expert in PV Quality Assurance? Apply now to drive quality improvements and ensure compliance in a leading pharmaceutical environment.