Job Title: QA Auditor – Pharmacovigilance (PV)
Department: Pharmacovigilance / Quality Assurance
Experience Required: 5+ Years (PV Systems), 3+ Years (Audits & QMS)
Role Overview
The QA Auditor – PV is responsible for ensuring the effectiveness and compliance of pharmacovigilance systems and quality processes. The role includes conducting audits, supporting inspections, and maintaining quality standards aligned with global pharmacovigilance regulations.
Key Responsibilities
1. Pharmacovigilance System Management
Implement and maintain pharmacovigilance (PV) systems
Ensure adherence to quality processes and performance metrics
Support continuous improvement of PV quality frameworks
2. Audit Execution
Conduct audits of:
Projects
Systems
Processes
Vendors
Ensure audits are performed in line with regulatory requirements and internal procedures
3. Inspection & Audit Support
Support preparation for customer audits and pharmacovigilance inspections
Assist in hosting audits and ensuring audit readiness
Contribute to timely closure of audit observations
4. Quality & Compliance
Ensure compliance with Global Pharmacovigilance Practices (GVP)
Maintain and monitor PV Quality Management Systems (QMS)
Support tracking and reporting of quality metrics
5. CAPA Management
Support identification of quality issues and audit findings
Assist in root cause analysis
Develop and track Corrective and Preventive Actions (CAPAs)
Ensure effectiveness and closure of CAPAs
Required Skills & Competencies
Strong understanding of pharmacovigilance principles and practices
Knowledge of global regulatory guidelines, especially GVP
Experience in audit planning, execution, and reporting
Familiarity with CAPA processes and quality systems
Strong analytical and problem-solving skills
Regulatory Knowledge
Good understanding of:
GVP (Good Pharmacovigilance Practices)
GCP (Good Clinical Practice)
Global pharmacovigilance regulations and guidelines
Preferred Experience
5+ years of experience in Global PV System Management (pharma companies or PV service providers)
3+ years of experience in conducting GCP and GVP audits
3+ years of experience managing PV Quality Management Systems
Experience in CAPA management
Personal Attributes
Detail-oriented with strong compliance focus
Effective communication and reporting skills
Ability to work independently and in cross-functional teams
Strong organizational and time management abilities
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