Matteo Nigro

Clinical Safety Specialist @Zambon

Bresso, IT

Supporting case processing activities and ensuring supervision and quality control of safety data present in the database, interacting with affiliates and CROs/consultants to ensure quality of entered data.Acting as the point of contact for study teams and CROs for all safety-related aspects of clinical studies.Contributing to the preparation of Safety Management Plans and Reconciliation Plans for clinical studies.Participating in periodic SAE reconciliation between the safety and the clinical database, and review of coding of adverse events, concomitant medications in the clinical database, interacting with relevant internal personnel and CROs.Providing investigators’ training on safety reporting aspects.Interacting with relevant competent authorities (e.g, EMA, MHRA, US FDA) to establish and maintain electronic transmission of ICSRs.Supporting generation and maintenance of policies, SOPs, and work instructions relevant to standardization and globalization of procedures for management of safety reports.