Pharmacovigilance/ Adverse event Reporting

Pharma Solutions Bangladesh Limited is compliant with Pharmacovigilance regulations. We ensure that Pharmacovigilance (PV) / Adverse Event (AE) are being managed correctly and efficiently.PSBL takes away the stress associated with PV / AE by supporting pharmaceutical and biopharmaceutical companies with all pharmacovigilance / Adverse Event needs: We carry out expedited case reporting; PV / AE report, preparation and submission; Safety Data Management & Global Safety Database; Qualified Person for PV/AE; and PV / AE Quality Assurance.

PSBL is in line with World Health Organization (WHO) definition of PV / AE as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems (WHO 2004). We acknowledge that the PV / AE system safeguards the public through competent and timely identification, collection, and assessment of medicine-related adverse events. Also, we communicate risks and benefits to support decision making about medicines at various levels of the healthcare system.

Pharma Solutions Bangladesh Limited has a comprehensive system that addresses the need for both active and passive approaches to identify medicines-related problems, effective mechanisms to communicate medicine safety information to healthcare professionals and the public.