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.
