PV Auditor (Contract / North America Sites)
Location: United States
Job Category: Pharmacovigilance / Quality Assurance
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About ProPharma:
For over 20 years, ProPharma has been a leading partner to biotech, medical device, and pharmaceutical companies, advancing scientific breakthroughs and introducing new therapies. Using an advise-build-operate model across the full product lifecycle, ProPharma provides expert consulting solutions in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology.
The Position:
ProPharma is seeking a contract-based PV (Pharmacovigilance) Auditor to lead clinical consulting and auditing projects across North America. This role will oversee the development, execution, and continual improvement of the GVP audit program, while providing risk-based assessments and consulting services to clients.
Responsibilities:
Execute GVP audits based on comprehensive knowledge of federal regulatory requirements, ICH-GCP, and GVP guidelines.
Lead and manage clinical compliance projects and consulting engagements.
Implement and oversee a risk-based GVP audit program.
Support clients in addressing clinical compliance issues, including deviation management and CAPA development.
Draft and review SOPs, audit reports, protocols, and other GxP documentation.
Promote GVP subject expertise through publications, professional networks, and presentations.
Keep abreast of advances in clinical support services, proposing improvements that enhance effectiveness and profitability.
Assist in staffing client projects based on skill development and client needs, including conducting candidate interviews.
Perform gap analyses, risk assessments, and data integrity audits for clients.
Provide mentorship and guidance to internal personnel on GVP and clinical compliance matters.
Maintain high quality standards across client projects for consistency, accuracy, and compliance.
Qualifications:
Strong working knowledge of international current GVP (cGVP) requirements and standards.
Expertise in quality systems, data integrity, and software compliance.
Experience in conducting GVP audits, gap analyses, and risk assessments.
Ability to manage and organize multiple projects simultaneously.
Exceptional attention to detail and quality orientation.
Strong editorial skills for reviewing GxP documentation.
Effective written and oral communication skills.
Proven ability to interact professionally with clients and internal teams.
Ability to mentor colleagues and promote a culture of clinical and GVP compliance.
Workplace Commitment:
ProPharma is deeply committed to creating an inclusive and empowering workplace. They celebrate differences, encourage innovation, and foster an environment where employees feel free to be their authentic selves.
Additional Information:
This position is not open to third-party agencies.
Please do not contact ProPharma by phone or email regarding this job posting.
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