Pharmacovigilance System Set-Up & QPPV

Biomapas supports Marketing Authorisation Holders and Applicants in the fulfillment of all pharmacovigilance obligations regarding medicinal products, including the establishment and maintenance of Pharmacovigilance System

We offer experienced EU Qualified Persons for Pharmacovigilance who are responsible for:

• Pharmacovigilance System set-up and development/maintenance of the Pharmacovigilance System Master File (PSMF);
• Implementation of ISO 90101:2015 Quality Management System aspects;
• Local pharmacovigilance representation in each of the country with the wide network of Biomapas Local Safety Officers (LSOs);
• Timely and quality full-scale processing of Individual Case Safety Reports (ICSRs);
• ICSRs records in E2B and CFR21 compliant Safety Database;
• EudraVigilance support, including mandatory ongoing medicinal product data reporting to XEVMPD;
• Regular global and local literature monitoring;
• Ongoing safety surveillance, signal detection validation, evaluation and further processing;
• Risk management, including the development of Risk Management Plans (RMPs) and risk minimization measures handling;
• Development and submission of Periodic Safety Update Reports (PSURs);
• Pharmacovigilance audit and inspection handling.