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Pharmacovigilance

Pharmacovigilance

Pharmacovigilance – the type of activity aimed to detect, assess, understand and prevent adverse consequences of drug administration.

Services:


  • Writing SOP (Standard Operating Procedures) with templates, logs and forms thereto necessary for functioning of pharmacovigilance and quality department;

  • Writing the Master File of the Pharmacovigilance System;

  • Personnel trainings for the customer company;

  • Writing PSURs (Periodic safety update reports);

  • Writing DSURS (Development safety update reports);

  • Audit of the pharmacovigilance system with a report and CAPA preparation (Corrective and Preventive Actions);

  • Audit of the quality system with a report and CAPA preparation (Corrective and Preventive Actions);

  • Monitoring of medical scientific literature and sites of regulatory bodies;

  • Obtaining, handling and work with Individual Safety Reports;

  • Management of safety signals;

  • Consulting on pharmacovigilance and quality;

  • Collection and analysis of adverse events in CT;

  • Writing Risk Management Reports;

  • Handling drug quality complaints;

  • Transfer of ADRs to regulatory bodies;

  • Medical expertise of safety cases;


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