Ph3Experteer Overview /h3pIn 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. 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. /ph3Retribuzione / Benefits /h3ulliPlan, prepare, conduct, document, and follow up on audits in Pharmacovigilance and Clinical Operations (on-site and remote) /liliPerform internal audits of Pharmacovigilance processes and systems, including GVP modules and procedures /liliAudit Pharmacovigilance vendors, distributors, licensees, licensors, and business partners /liliAudit computerized systems supporting Pharmacovigilance and Clinical activities (validated systems) per GAMP 5 and applicable laws /liliAudit company affiliates for global Pharmacovigilance and Clinical Quality Systems /liliConduct qualification audits of CROs for clinical trials /liliPerform study-specific audits (Phase I–IV, BE studies, PAs) /liliAudit clinical processes, systems, and quality management for trials /liliAudit eCRF, TMF, CSR, and related documentation /liliConduct on‑site audits at clinical investigator sites /liliAudit clinical vendors and service providers /liliEvaluate audit findings, assess risk and criticality, and prepare audit reports /liliMonitor CAPA plans and effectiveness in Veeva QMS /liliSupport inspection readiness and regulatory inspection activities /liliContribute to continuous improvement within Quality Assurance /li /ulh3Responsabilità /h3ulliSolid experience in pharmaceutical, biotechnology, or clinical research industry /liliMinimum 5 years in Quality Assurance, Clinical Operations, Pharmacovigilance, or auditing in a regulated GxP environment /liliProven experience conducting GCP and GVP audits, including vendor and system audits /liliStrong analytical and problem‑solving skills /liliExcellent written and spoken communication, with ability to present findings /liliStrong conflict‑resolution and negotiation skills /liliDiplomatic and effective interaction with diverse stakeholders /liliAbility to work independently and manage audits from planning to closure /liliExperience in international and multicultural environments /liliStrong organizational skills and ability to handle multiple priorities under tight timelines /liliHigh integrity, discretion, and confidentiality /li /ul /p #J-18808-Ljbffr