Pharmacovigilance

Mesned Pharmacovigilance Center MPVC is the first and only licensed Pharmacovigilance Center in Saudi Arabia and GCC Area that offers a fully compliant and high-quality comprehensive package of Pharmacovigilance services, we are committed to patient safety and is willing and ready to collaborate with clients to meet the increasingly complex regulatory requirements in Pharmacovigilance in KSA and GCC Area. Our full range of services offer flexible technologies, resourcing solutions, effective governance and continuous process improvement from early clinical development to marketed product support, through efficiencies, maintaining quality and adhering to regulations.

Number one goal of MPVC is to ensure that reporting obligations are in line with SFDA and applicable regulatory guidelines and to help our customers meet the strict regulatory requirements, along with managing the safety and risk-benefit profile of the products, in order to maximize product potential, whilst ensuring patient safety.

Mesned Pharmacovigilance Center (MPVC) Services

• Provide Authorized local Saudi QPPV and Deputy on behalf of the clients.
• Revision, Evaluation & Submission of Individual Case Safety Reports (ICSRs).
• Provide Software database for converting the ICSRs to E2B(R2) XML.
• Support the customers by providing the services, Review, Evaluation & Submission for Periodic Safety Update Reports (PSURs), Risk Management Plans {RMPs), Pharmacovigilance System Master File (PSMF) and national Pharmacovigilance Sub-System File {PSSF).
• Prepare of KSA Appendices “KSA specific PSUR requirements”.
• Literature Review for local Saudi journals and all GCC countries.
• MedDRA Coding and Coding Convention Strategies.
• Pharmacovigilance training with CME from Introductory to Advanced courses.
• Training of Medical Representatives on Pharmacovigilance and Management of ICSRs.
• Preparation of complete set of Pharmacovigilance SOPs.
• Preparation of Pharmacovigilance Quality Management System (QMS).
• Assist in preparation of external audits and inspections.