Global Pharmacovigilance Auditor Lead

Kaztronix; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Kaztronix is seeking a Senior Pharmacovigilance Auditor to lead global PV audits of vendors and internal teams. The role requires strategic oversight of regulatory compliance, GxP standards, and continuous quality improvement across functions.

Expect international travel and collaboration with QA, PV, Clinical Operations, and Regulatory Affairs to ensure inspection readiness and CAPA effectiveness. A strong background in PV auditing and relevant certifications is preferred.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field.
• 8+ years of Pharmacovigilance, Quality Assurance, or GxP auditing experience.
• Extensive experience auditing vendors and third‑party pharmacovigilance operations.
• Strong knowledge of FDA, EMA, ICH regulations and global PV requirements.
• Ability to interpret audit protocols and assess compliance strategically.
• Experience reviewing audits, inspection findings, and CAPA trends.

Responsibilities

• Plan, conduct, and lead global PV audits of vendors, service providers, affiliates, and internal departments.
• Travel extensively for domestic and international on-site audits.
• Evaluate compliance with global PV regulations, GVP/GCP, and contractual obligations.
• Review protocols, SOPs, quality agreements, and regulations to devise audit strategies.
• Assess vendor quality systems, case processing, signal management, and risk management.
• Prepare audit plans, conduct interviews, document observations, and write reports.
• Evaluate CAPA effectiveness and verify closure with stakeholders.
• Collaborate with QA, PV, Regulatory, and external vendors to improve compliance.
• Support inspection readiness and regulatory inspections when required.

Skills

PV auditing

Regulatory interpretation

Audit reporting

Interviewing & stakeholder mgmt

Quality metrics analysis

GxP familiarity

Education

Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related

ASQ CQA OR ISO Lead Auditor OR RQAP

Tools

Veeva Vault Quality

Job description

Kaztronix is seeking a Senior Pharmacovigilance Auditor to lead global PV audits of vendors and internal teams. The role requires strategic oversight of regulatory compliance, GxP standards, and continuous quality improvement across functions.

Expect international travel and collaboration with QA, PV, Clinical Operations, and Regulatory Affairs to ensure inspection readiness and CAPA effectiveness. A strong background in PV auditing and relevant certifications is preferred.