Senior PV Auditor (3 Openings)

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

Senior Pharmacovigilance (PV) Auditor

Position Summary

We are seeking an experienced Senior Pharmacovigilance (PV) Auditor to lead and execute global pharmacovigilance audits across internal functions and external business partners. This role requires a strategic auditor with extensive knowledge of global PV regulations, GxP compliance, and vendor oversight. The successful candidate will travel internationally to conduct on-site audits, assess compliance with regulatory requirements, and identify opportunities for continuous quality improvement.

Key Responsibilities

• Plan, conduct, and lead global pharmacovigilance audits of vendors, service providers, affiliates, and internal departments.
• Travel extensively to perform domestic and international on-site audits.
• Evaluate compliance with global pharmacovigilance regulations, GVP/GCP requirements, company procedures, and contractual obligations.
• Review audit protocols, quality agreements, SOPs, and applicable regulations to develop effective audit strategies.
• Assess vendor quality systems, pharmacovigilance processes, case processing, signal management, risk management activities, and safety reporting practices.
• Review historical audit reports, CAPAs, inspection findings, and quality metrics to identify trends and areas of risk prior to conducting audits.
• Prepare detailed audit plans, execute interviews, review documentation, and document observations in comprehensive audit reports.
• Evaluate the effectiveness of corrective and preventive actions (CAPAs) and verify implementation.
• Partner with Quality Assurance, Pharmacovigilance, Clinical Operations, Regulatory Affairs, and external vendors to drive compliance improvements.
• Support inspection readiness activities and regulatory inspections when required.
• Maintain audit schedules and contribute to the annual global audit program.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related scientific discipline; advanced degree preferred.
• 8+ years of Pharmacovigilance, Quality Assurance, or GxP auditing experience within the pharmaceutical or biotechnology industry.
• Extensive experience performing vendor and third-party pharmacovigilance audits.
• Strong understanding of global pharmacovigilance regulations, including FDA, EMA, ICH, and other international regulatory requirements.
• Demonstrated ability to interpret audit protocols and strategically assess compliance against applicable requirements.
• Experience reviewing previous audits, inspection findings, and quality trends to develop risk-based audit strategies.
• Strong analytical, investigative, and report-writing skills.
• Excellent interviewing, communication, and stakeholder management abilities.
• Experience using electronic Quality Management Systems, including Veeva Vault Quality or comparable platforms.
• Professional auditor certifications (ASQ CQA, RQAP, ISO Lead Auditor, or equivalent) are preferred.

Preferred Experience

• Experience auditing complex global pharmacovigilance vendors and outsourced safety organizations.
• Ability to perform approximately 2 audits per month while managing multiple audit activities simultaneously.
• Experience supporting a high-volume global audit program involving hundreds of vendor audits annually.
• Multilingual capabilities are highly desirable to support worldwide audits and interactions with international stakeholders.
• Experience working across North America, Europe, Asia-Pacific, and other global regions.

Travel Requirements

• Approximately 50–75% international and domestic travel.
• Ability to travel globally to vendor locations and company sites throughout the year.

Core Competencies

• Strategic auditing and risk assessment
• Vendor qualification and oversight
• Global pharmacovigilance compliance
• CAPA evaluation and effectiveness verification
• Regulatory inspection readiness
• Cross-functional collaboration
• Excellent written and verbal communication
• Strong organizational and project management skills

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.