Advancing clinical research: safer, smarter, faster
Pharmaceutical Quality GVP Auditor – Consulting
Location
Japan
Posted
6 days ago
Salary
0
Seniority
Lead
Job Description
Pharmaceutical Quality GVP Auditor – Consulting
Advarra
• 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.
Job Requirements
- 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
- Inclusive and collaborative environment
- Committed to respect and embrace diverse perspectives
- Empathy and care towards clients and trial participants
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