Pharmaceutical Quality GVP Auditor – Consulting

Advarra

Join Advarra as a GVP Auditor for Japan-based projects. Focus on compliance reviews, audits, and quality assurance in clinical trials.

Posted 7/9/2026part-timeRemote • 🇯🇵 JapanLeadWebsite

About the role

Key responsibilities & impact

Conduct Good Pharmacovigilance Practice (GVP) audits (planning, agenda, physical or remote audit, and report writing)
Evaluate investigator sites, CROs, and vendor compliance or qualification.
Prepare comprehensive audit reports detailing findings and root-causes.
Provide written audit reports in English.
If required will provide corrective actions support and present findings to QA leadership and stakeholders
Work collaboratively with clients to ensure quality standards.

Requirements

What you’ll need

Minimum 10+ years of Clinical Quality Assurance and/or Pharmacovigilance Practice (GVP) experience.
Minimum 5+ years of Pharmacovigilance Practice (GVP) auditing experience.
Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
B2 level in English communication, verbal and written
B2 level in Japanese communication, verbal and written
Bachelor's degree

Benefits

Comp & perks

Inclusive and collaborative environment
Committed to respect and embrace diverse perspectives
Empathy and care towards clients and trial participants

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Good Pharmacovigilance Practice (GVP) AuditsAudit Report WritingRegulatory Compliance EvaluationCorrective Action Plan DevelopmentQuality Assurance Program Implementation

Soft Skills

Collaborative WorkStakeholder Presentation