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Location
This role is open to candidates based in North America.
Company Information
At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.
Company Culture
Our people--both employees and consultants-are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.
Job Overview Summary
Advarra is seeking Good Pharmacovigilance Practice (GVP) Auditors to join our consultant network for North America -based projects. Auditors support compliance reviews across GVP clinical sites and vendors.
Job Duties & Responsibilities
• 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.
Basic Qualifications
• 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
• Bachelor's degree
Preferred Qualifications
• Strong interpersonal and client interaction skills.
• Excellent analytical, problem-solving, communication, and report-writing skills.
• Ability to work collaboratively across departments and interact with internal and external stakeholders.