Overview In this role you will carry out pharmacovigilance (PV) operations for interventional clinical trials, ensuring compliant, high-quality safety data and up-to-date processes. You'll work with global teams and CROs to support PV requirements across R&D; assets. You will train staff, oversee audits, and drive process improvements within a collaborative, international environment. This position offers a clear impact on patient safety and regulatory excellence at Chiesi. Responsibilities Support CT PV OPS processes and ensure PV requirements are embedded in Chiesi procedures Coordinate collection, assessment and timely delivery of safety data to agencies Engage CT customers,



affiliates and stakeholders across the organization Act as subject matter expert for PV OPS processes and provide training Support Case Management activities with PVSPs Interact with Safety Science for product-specific safety data inputs Supervise PV operations-related sections of trial documents and oversee CRO activities Ensure PV data capture in PSMF and manage deviations/CAPA implications Lead post-integration PV OPS activities for R&D; assets Serve as PV OPS expert during GVP and GCP audits and inspections Participate in GRAPS process improvement initiatives Maintain compliance with regulations, policies and procedures Qualifications Master degree in science, medicine, biology, pharmacy or related fields Minimum 4 years in R&D; in Pharmaceutical/Biotechnology, with at least 3 years in Pharmacovigilance or Clinical Research Willingness to operate in a diverse, international environment Excellent communication and interpersonal skills Ability to work with initiative and autonomy Problem solving and decision making skills Planning and analytical skills Fluent English Benefits pension private medical insurance wellbeing programme flexible benefits programme relocation support remote work options #J-18808-Ljbffr

📌 Patient safety operations manager (Italia)
🏢 Experteer Italy
📍 Italia