Job Description
- 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
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