Clinical & PV Auditor Recordati, a global pharmaceutical company founded in the 1920s, is seeking a Clinical & Pharmacovigilance Auditor to strengthen its Quality Assurance function. The role ensures compliance of clinical development activities and the pharmacovigilance system with international and local regulatory requirements, internal procedures and Recordati quality standards. Job Purpose Independently plan, conduct, report and follow up on audits related to Clinical Operations and Pharmacovigilance activities. Verify compliance, contribute to continuous improvement of quality systems, patient safety and data integrity, and support inspection‐readiness projects. Key Responsibilities * Plan, prepare, conduct, document, and follow up on audits in Pharmacovigilance and Clinical Operations, on‐site and remotely. * Conduct internal audits of Pharmacovigilance processes and systems, ensuring compliance with GVP modules and company procedures. * Audit Pharmacovigilance vendors, distributors, licensees, licensors and business partners.



* Audit computerized systems supporting Pharmacovigilance and Clinical activities, validated by GAMP 5 principles and applicable legislation. * Perform audits of company affiliates to assess compliance with global Pharmacovigilance and Clinical Quality Systems. Clinical Auditing Responsibilities * Conduct qualification audits of CROs responsible for clinical trial conduct. * Perform study‐specific audits (Phase I–IV, bioequivalence studies, Post‐Authorization studies). * Audit clinical processes, procedural systems, and quality management frameworks supporting clinical trials. * Audit electronic Case Report Forms (eCRF), Trial Master File (TMF), Clinical Study Reports (CSR) and associated documentation. * Conduct on‐site audits at clinical investigator sites where studies are performed. * Perform audits of clinical vendors and service providers. Compliance Activities * Evaluate audit findings, assess risk and criticality, and prepare cl

📌 Clinical & PV Auditor (Italia)
🏢 Recordati
📍 Italia