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

Core Competencies

Role fit

Core Competencies

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Expertise in conducting Good Pharmacovigilance Practice (GVP) audits and preparing comprehensive audit reports, with a strong focus on regulatory compliance and quality assurance. Proficient in developing corrective action plans and collaborating with stakeholders to uphold quality standards.

Highest-signal resume keywords

Clinical Quality Assurance ExperiencePharmacovigilance Practice AuditingRegulatory Agency Compliance (FDA, EMA)Quality Assurance Plan DevelopmentB2 Level English and Japanese Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

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

Soft Skills

Collaborative WorkStakeholder Presentation

Industry Keywords

Clinical Quality AssurancePharmacovigilanceAudit Readiness ActivitiesInvestigator Site EvaluationCRO Compliance

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