We are seeking an experienced freelance Senior Auditor to perform pharmacovigilance system audits on behalf of a leading pharmaceutical company. The consultant will be responsible for independently planning, conducting, and reporting GVP audits in accordance with applicable regulatory requirements, internal quality standards, and contractual agreements.
The ideal candidate is a qualified and experienced GVP auditor with a solid understanding of pharmacovigilance systems, regulatory expectations, and best industry practices. Knowledge of Good Clinical Practice (GCP) is considered an advantage.
Responsibilities
* Plan, prepare, and execute GVP audits of internal systems, affiliates, vendors, and service providers on behalf of the sponsoring company.
* Conduct audits in compliance with EU GVP, ICH guidelines, and other relevant international regulations.
* Prepare and deliver comprehensive audit reports, identifying key findings, risks, and opportunities for improvement.
* Collaborate with the company’s Quality Assurance and Pharmacovigilance teams to ensure audit program alignment and risk-based coverage.
* Maintain confidentiality and impartiality in all audit-related activities, acting as an independent quality representative of the company.
* Perform remote and on-site audits of global pharmacovigilance systems, processes, and service providers.
* Assess compliance with pharmacovigilance agreements (PVAs) and global safety reporting obligations.
* Identify and document compliance risks and process gaps, providing expert recommendations.
* Write the final audit report.
Experience
* Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
* Minimum of 5–8 years of professional experience in pharmacovigilance and quality assurance in the pharmaceutical or biotechnology industry.
* At least 5 years of proven experience as a lead or senior GVP auditor, ideally performing audits for or on behalf of marketing authorization holders or service providers.
* Formal auditor qualification or certification (e.g., ISO 9001 Lead Auditor, IRCA, or equivalent) preferred.
* Excellent knowledge of EU GVP and other applicable pharmacovigilance regulations.
* Working knowledge of GCP and clinical safety processes is an advantage.
* Strong analytical, organizational, and report-writing skills with attention to detail.
* Demonstrated ability to work independently and manage multiple audits within agreed timelines.
* Fluent in English (written and spoken); additional languages are an asset.
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