Auditor - GVP

Role: GVP Auditor within the Research & Development Quality audit program, responsible for executing global pharmacovigilance audits to ensure safety data accuracy and regulatory compliance. Responsibilities: conduct external audits of PV vendors and internal safety processes, develop comprehensive audit reports with risk assessments, identify non-compliance trends, and support continuous improvement initiatives aligned with EMA GVP guidelines and global regulations. Maintain current knowledge of pharmacovigilance regulations and industry best practices. Requirements: BS in biological sciences, pharmacy, or related field; proven QA experience in GVP-regulated environments; expertise in PV audits and inspection management; strong communication skills for multinational stakeholder engagement. HighValue: extensive knowledge of ICH GVP modules, 21 CFR parts relevant to drugs and biologics, EMA regulations, and compliance frameworks; experience in risk-based audit planning; ability to work independently with up to 50% travel. WorkSetup: global role with significant travel, supporting pharmaceutical safety compliance.