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.