Pharmacovigilance services

 A 360ยบ Services including but not limited to:

 

 Implementing a Complete PV System

  • Establishment of a regional or local QPPV, 24/7/365 available and with access to a Medical Doctor;
  • Gap-Analysis, Elaboration and Maintenance of the PSMF and other PV SOPs;
  • Establishment of the PV case management specialist responsible for ICSR registration and establishment of its Argus electronic Reporting;
  • Elaboration of the Technical Agreements - Safety Data Exchange Agreement.

 

 Performing all mandatory ongoing activities

  • Elaboration of CIOMS Reports;
  • Perform a continuous safety profile monitoring and benefit-risk evaluation;
  • Perform a Constant Signal Management;
  • Elaboration of Compliance Reports;
  • Perform Local and Worldwide Literature Monitoring;
  • Perform a Periodic Reconciliation with the Clients;
  • Pharmacovigilance in Clinical Trials.

 

Provide other punctual activities that might be needed

  • Performance of Pharmacovigilance Audits and issuance of the applicable Audit Reports;
  • Training in Pharmacovigilance;
  • Perform Safety Variations;
  • Install Safety Urgent Measures;
  • Elaboration of Periodic Safety Update Reports;
  • Elaboration of Risk Management Plans.