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MANAGEMENT SYSTEM GUARANTEEING QUALITY: ISO 13485 AND ISO 9001

Pharmacovigilance is all the activities finalized for identifying, evaluating, understanding and preventing adverse effects correlated with the use of medicines, with the aim of assuring a favourable benefit/risk relationship for the users.

SCF offers to its clients a complete management in outsourcing of the service of pharmacovigilance, through the certified Qualified Person for European Pharmacovigilance (EU-QPPV), to carry out all the activity that a pharmaceutical company has to guarantee, to be compliant with the pharmacovigilance legislation in force, through the implementation of:

  • a management system for the quality of Pharmacovigilance and relative Standard Operating Procedure (SOP),

  • Periodic Safety Update Reports (PSUR),

  • Risk Management Plan (RMP),

  • Activity of monitoring of the National Pharmacovigilance Network (RNF) as referring company,

  • Monitoring of national and international scientific literature for medical products and active substances,

  • Preparation, maintenance and updating of the Pharmacovigilance System Master File (PSMF),

  • Management of the Safety Reports in Eudravigilance,

  • Updating of medical products in the European database Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)

  • Taking on the role of Local contact point,

  • Planning, conduction and reporting of Pharmacovigilance audit and relative management and planning of corrective and preventative actions from an audit.
  • Manuale di qualità e relative SOP:
    • Piano di gestione dei rischi (RMP);
    • Gestione dei rapporti con l’ente di certificazione;
    • Assistenza in corso di audit.

Moreover, pharmacovigilance activities could be performed also during the conduction of clinical studies through:

  • Preparation of the specific SOP,

  • Full-time receiving and reporting of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) through Eudravigilance,

  • Preparation and transmission to the competent authorities of the Developed Safety Update Reports (DSUR).

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