Pharmaceutical Quality GVP Auditor – Consulting

This is a fully remote position, open to applicants in Japan.

📋 Description

• Execute Good Pharmacovigilance Practice (GVP) audits, including planning, agenda setting, conducting physical or remote audits, and report preparation.

• Assess compliance or qualification of investigator sites, CROs, and vendors.

• Develop detailed audit reports that outline findings and identify root causes.

• Provide audit reports in English, ensuring clarity and thoroughness.

• If necessary, offer support for corrective actions and present findings to QA leadership and stakeholders.

• Collaborate effectively with clients to uphold quality standards.

⛳️ Requirements

• At least 10 years of experience in Clinical Quality Assurance and/or Good Pharmacovigilance Practice (GVP).

• A minimum of 5 years of experience in auditing Good Pharmacovigilance Practice (GVP).

• Proven knowledge of regulatory agency expectations (such as FDA, EMA) and readiness for audits.

• Demonstrated ability to develop and implement quality assurance plans, audit programs, and corrective action plans.

• Proficiency in English communication at a B2 level, both verbal and written.

• Proficiency in Japanese communication at a B2 level, both verbal and written.

• Bachelor's degree required.

🏝️ Benefits

• An inclusive and collaborative work environment.

• A commitment to respecting and embracing diverse perspectives.

• A culture of empathy and care towards clients and trial participants.