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.

Docente: Master Management e Marketing dell’Industria Farmaceutica >>>