Rafael dos Santos

Safety Vigilance Senior Manager Nanobiotix Sa @Hays

Paris, FR

Serve as a representative for pharmacovigilance (PV) and materiovigilance (MV) for clinical trials and organized data collection activities such as investigator-initiated trials/studies. Contribution to ongoing safety data review activities such as Data Evaluation Meetings, Coding Quality Control (MedDRA, WHODRUG), Signal Detection, etc. Liaise cross-functionally with the Biostatistics and Data Management departments in the Clinical Database, Clinical Development, Clinical Operations, Legal Affairs, Medical Affairs, Product Quality, Regulatory Affairs and others as required to ensure that processes are in place for activities performed by functions that impact all PV and MV activities. Produce the PV and MV management plan including the case submission strategy, the production of forms. Production or review of the PV and MV part of key documents such as protocols and investigator\'s brochures. Provides PV and MV support during reconciliations between the pharmacovigilance database and clinical databases. Participation in clinical study team meetings as a representative of the \"safety\" department. Monitoring the changes made to the Pharmacovigilance/Medical Devices regulations (including Materiovigilance) in force and adapted processes. Management of Safety Vigilance documents, as part of the quality management system. Contribution to the activities of the Safety Vigilance Department and establishment of a harmonious collaboration, interactions and exchange of information with other structures. Ensures compliance with procedures and regulatory requirements. Communicates new regulations or changes in regulations to relevant members of different departments to identify and initiate changes in processes. Prepares and participates in audits and inspections. Management of periodic reports. Representative of PV and MV in the context of clinical trials. Monitoring of submissions related to PV and MV.

Groupe IFIS

Certificat de formation professionnelle, Matériovigilance

Pós Graduação - Faculdades Oswaldo Cruz

Post-graduation, Clinical Pharmacology

USP - Universidade de São Paulo

Bachelor of Pharmacy - BPharm, Sciences pharmaceutiques