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.
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:
• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off