Auditor - GVP

Role: GVP Auditor responsible for executing global pharmacovigilance (PV) audits to ensure safety data accuracy and compliance with regulatory standards. Responsibilities: conduct external audits of PV vendors, internal safety processes, and affiliate activities; develop detailed audit reports, categorize findings by risk, and recommend CAPAs; analyze non-compliance trends and communicate risks to support PV system integrity; assist in updating SOPs and ensuring adherence to EMA GVP modules and global regulations; maintain current knowledge of PV regulatory landscape. Requirements: BS in biological sciences, pharmacy, or related field; proven QA experience in GVP-regulated environments with audit expertise; strong understanding of drug safety operations, ICH GVP guidelines, and relevant regulatory frameworks (e.g., EMA, FDA). Skills: excellent communication and stakeholder management skills; analytical, problem-solving abilities; ability to work independently with up to 50% travel. HighValue: pharmacovigilance, GVP compliance, PV audits, EMA/GVP regulations, risk-based assessments, global safety systems. WorkSetup: flexible location with significant travel.