Advarra
501 - 1000 employees
Founded 1983
☁️ SaaS
🤖 Artificial Intelligence
Healthcare • SaaS • Artificial Intelligence
Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.
Freelance Pharmaceutical Quality GVP Auditor
🕒 March 27
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Advarra
501 - 1000 employees
Founded 1983
☁️ SaaS
🤖 Artificial Intelligence
Healthcare • SaaS • Artificial Intelligence
Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.
📋 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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