Clinical & PV Auditor

Experteer Overview  In 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.
Retribuzione / Benefits   Plan, 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 procedures
Audit Pharmacovigilance vendors, distributors, licensees, licensors, and business partners
Audit computerized systems supporting Pharmacovigilance and Clinical activities (validated systems) per GAMP 5 and applicable laws
Audit company affiliates for global Pharmacovigilance and Clinical Quality Systems
Conduct qualification audits of CROs for clinical trials
Perform study-specific audits (Phase I–IV, BE studies, PAs)
Audit clinical processes, systems, and quality management for trials
Audit eCRF, TMF, CSR, and related documentation
Conduct on‑site audits at clinical investigator sites
Audit clinical vendors and service providers
Evaluate audit findings, assess risk and criticality, and prepare audit reports
Monitor CAPA plans and effectiveness in Veeva QMS
Support inspection readiness and regulatory inspection activities
Contribute to continuous improvement within Quality Assurance
Responsabilità   Solid experience in pharmaceutical, biotechnology, or clinical research industry
Minimum 5 years in Quality Assurance, Clinical Operations, Pharmacovigilance, or auditing in a regulated GxP environment
Proven experience conducting GCP and GVP audits, including vendor and system audits
Strong analytical and problem‑solving skills
Excellent written and spoken communication, with ability to present findings
Strong conflict‑resolution and negotiation skills
Diplomatic and effective interaction with diverse stakeholders
Ability to work independently and manage audits from planning to closure
Experience in international and multicultural environments
Strong organizational skills and ability to handle multiple priorities under tight timelines
High integrity, discretion, and confidentiality

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