Auditor - PV

Job description

Quality in a globalized drug safety network is a matter of operational resilience as much as regulatory mandate. This role serves as a PV Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of safety data and compliance with legal and corporate standards. By conducting audits of our external partners and internal safety functions, you identify the findings and non-compliance trends that could impact the reliability of our pharmacovigilance system. We are looking for an experienced auditor who can navigate complex safety environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability. Main Responsibilities: - Audit Execution: Conduct assigned external audits of pharmacovigilance vendors and service providers, as well as internal self-inspections of safety processes, procedures, and Local/Regional Safety Officers (LSO/RSOs). - Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to drug safety an...