Auditor - GVP

Role: GVP Auditor within the global pharmacovigilance quality audit program, responsible for executing audits of external vendors and internal safety processes to ensure compliance with GVP guidelines and regulatory standards. Responsibilities include conducting audits, reporting findings, risk categorization, trend analysis of non-compliance, and supporting continuous improvement initiatives for pharmacovigilance systems and SOPs. Requirements: BS in biological sciences, pharmacy, or related field; proven QA experience in a GVP-regulated environment; expertise in pharmacovigilance audits; strong communication and stakeholder engagement skills; working knowledge of ICH GVP modules, 21 CFR parts, EMA regulations, and industry guidelines. Preferred qualifications include familiarity with audit management and inspection processes. High-value specifics: focus on pharmacovigilance compliance, GVP modules, EMA and FDA regulations, with up to 50% travel requirement. Work setup not specified, but the role involves global stakeholder interaction and audit execution.