Advarra
Advancing clinical research: safer, smarter, faster
Pharmaceutical Quality GVP Auditor – Freelance/Independent Consulting
Location
United States
Posted
2 days ago
Salary
Not specified
Seniority
Lead
Bachelor Degree10 yrs expEnglish
Job Description
• 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 Good Pharmacovigilance Practice (GVP) experience.
- Minimum 5+ years of Good Clinical Practices 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.
- Fluent English communication, verbal and written.
Benefits
- Remote work options
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