Experteer OverviewIn this role you will independently plan, conduct, and follow up on audits across Clinical Operations and Pharmacovigilance to ensure compliance with international and local regulations and Recordati standards. Si assicuri che tutte le informazioni della sua candidatura siano aggiornate e corrette prima di cogliere questa occasione. You will work in a global, cross-functional Quality Assurance team, engaging with internal departments and external partners to strengthen quality systems, patient safety, and data integrity. You will drive inspection readiness and continuous improvement through risk assessment and effective audit reporting. This is a technically demanding role with a strong impact on regulatory compliance and quality culture across the organization.Retribuzione / BenefitsPlan, prepare, conduct, document, and follow up on audits in Pharmacovigilance and Clinical Operations (on-site and remote)Perform internal audits of Pharmacovigilance processes and systems, including GVP modules and proceduresAudit Pharmacovigilance vendors, distributors, licensees,



licensors, and business partnersAudit computerized systems supporting Pharmacovigilance and Clinical activities (validated systems) per GAMP 5 and applicable lawsAudit company affiliates for global Pharmacovigilance and Clinical Quality SystemsConduct qualification audits of CROs for clinical trialsPerform study-specific audits (Phase I–IV, BE studies, PAs)Audit clinical processes, systems, and quality management for trialsAudit eCRF, TMF, CSR, and related documentationConduct on‐site audits at clinical investigator sitesAudit clinical vendors and service providersEvaluate audit findings, assess risk and criticality, and prepare audit reportsMonitor CAPA plans and effectiveness in Veeva QMSSupport inspection readiness and regulatory inspection activitiesContribute to continuous improvement within Quality AssuranceResponsabilitàSolid experience in pharmaceutical, biotechnology, or clinica

📌 Clinical & Pv Auditor (Italia)
🏢 Experteer Italy
📍 Italia