Mesned Pharmacovigilance Center (MPVC)
The premier and exclusive licensed Pharmacovigilance Center in Saudi Arabia and the GCC region. We provide a comprehensive and high-quality suite of Pharmacovigilance services, fully aligned with regulatory standards. MPVC is dedicated to ensuring patient safety and is prepared to collaborate with clients to navigate the increasingly complex regulatory landscape of Pharmacovigilance in Saudi Arabia and the GCC.
Our extensive service offerings include flexible technological solutions, resourcing options, effective governance, and continuous process improvement. Supporting clients throughout product lifecycle, including early clinical development to post-marketing, which results in emphasizing efficiency, quality, and regulatory compliance.
Our primary objective at MPVC is to comply with SFDA reporting obligations and relevant regulatory guidelines. We are committed to helping the clients meet stringent regulatory requirements while effectively managing the safety and risk-benefit profile of their products. Our goal is to maximize product potential while safeguarding patient safety.
Mesned Pharmacovigilance Center (MPVC) Services
Provision of Authorized Local Saudi QPPV and Deputy: We offer authorized local Qualified Person for Pharmacovigilance (QPPV) and Deputy services on behalf of our clients.
ICSR Management: We handle the revision, evaluation, and submission of Individual Case Safety Reports (ICSRs).
Software Database Conversion: We provide software solutions for converting ICSRs to E2B(R2) XML format.
Periodic Reporting Support: We assist with the review, evaluation, and submission of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Pharmacovigilance System Master File (PSMF), and national Pharmacovigilance Sub-System File (PSSF).
KSA Appendices Preparation: We prepare Saudi Arabia-specific PSUR appendices.
Literature Review: We conduct literature reviews for local Saudi journals and other GCC countries.
MedDRA Coding: We provide MedDRA coding and develop coding convention strategies.
Pharmacovigilance Training: We offer pharmacovigilance training, including Continuing Medical Education (CME) from introductory to advanced levels.
Training of Medical Representatives: We train medical representatives on pharmacovigilance practices and the management of ICSRs.
SOP Development: We prepare comprehensive sets of Pharmacovigilance Standard Operating Procedures (SOPs).
Quality Management System (QMS): We develop Pharmacovigilance Quality Management Systems (QMS).
Audit and Inspection Support: We assist in preparing for external audits and inspections.
