QA Auditor – Pharmacovigilance (PV)
Location: [Not Specified]
Experience: 5+ years
Job Type: Full-Time
Job Overview:
We are currently seeking an experienced QA Auditor – PV to join our Pharmacovigilance Quality Assurance team. This role focuses on maintaining robust PV systems, conducting audits, and ensuring compliance with global pharmacovigilance regulations. You will be instrumental in preparing for inspections, evaluating vendors, managing CAPAs, and supporting PV quality initiatives across the organization.
Key Responsibilities:
Pharmacovigilance System Management:
Implement, manage, and continually improve the PV Quality Management System (QMS)
Develop and monitor quality metrics for PV activities
Ensure compliance with global regulatory PV requirements and internal SOPs
Audit & Compliance:
Conduct audits of internal processes, systems, projects, and third-party vendors in line with GVP and GCP requirements
Identify quality and compliance gaps, provide risk-based assessments, and issue audit reports
Support audit readiness and host client audits and regulatory inspections
CAPA Oversight:
Oversee timely and effective implementation of Corrective and Preventive Actions (CAPAs)
Monitor CAPA trends and ensure lessons learned are communicated across teams
Candidate Profile:
Education: Life Science, Pharmacy, or equivalent degree
Experience:
5+ years of experience in global pharmacovigilance system management within a pharma company or PV service provider
Minimum 3 years conducting GVP and/or GCP audits
3+ years managing PV Quality Management Systems (QMS)
Proven track record in CAPA management and audit follow-up
Knowledge & Skills:
In-depth knowledge of GVP modules and global PV regulations
Strong understanding of pharmacovigilance practices and audit methodologies
Excellent attention to detail and analytical thinking
Effective communication and documentation skills
Ability to work cross-functionally and independently
Estimated Salary: ₹12 – ₹18 LPA (depending on experience and organization scale)
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