Laurata in Chimica, inizio a lavorare in Novo Nordisk come prima esperienza in un'azienda farmaceutica nel 2006. Inizio il mio percorso come Medical Advisor per poi passare al mondo del Regolatorio e della Farmacovigilanza fino a diventare responsabile del dipartimento per l'Italia e Malta. Dopo 14 anni decido di intraprendere un nuovo percorso ed entrare a far parte dell'organico della Vertex Pharmaceuticals in Italia.
Le responsabilità rimangono sempre legare al Regolatorio, ambito che non saprei più lasciare proprio per la caratteristica di abbracciare l'azienda a 360°.
Regulatory Affairs & Safety Manager
• Regulatory activity management for Italy and Malta:
• Translating product information (SPC, PIL, Label, Carton);
• Proof-reading of packaging materials ;
• Supporting product file submission to HA;
• Providing regulatory approval of promotional activities/material ;
• Supporting Regulatory Budget;
• Update of local regulatory SOPs ;
• Updating on regulatory and safety legislation;
• Supporting QAP forecast and monitoring;
• Responsible for Safety and Pharmacovigilance:
• Pharmacovigilance activity management ;
• Customer Complaint activity management;
• Update of local safety SOPs;
• Training NNI personnel on compliance of Italian regulatory environment;
Regulatory Affairs Specialist
• Support in Regulatory activity management for Italy and Malta:
• Translating product information (SPC, PIL, Label, Carton);
• Proof-reading of packaging materials ;
• Supporting product file submission to HA;
• Update of local regulatory SOPs ;
• Updating on regulatory and safety legislation;
• Support in Safety and Pharmacovigilance activities;
Regulatory & Medical Affairs Officer
Medical Advisor
Reporting to the Local Trial Manager, handling of start-up documentation and monitoring of clinical trials especially for observational studies;
• Management of medical records related to drugs in accordance with SOPs, GCP and ICH;
• contacts with KOLs for the initiation phase, operation and final reports of clinical trials;
• updating and reporting of clinical research activities;
• scientific support for the product specialists and Marketing Department.
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