Our team is experienced in handling end to end case processing of spontaneous, literature and clinical trial origin ICSRs using Argus, ARISg, PvNet, ABCube, BaseCon & Eudravigilance databases. We, in association with European solution providers offer a pharmacovigilance technology platform solution that helps clients reduce manual effort in ICSRs processing.
Pharmavigil experts place particular emphasis on the timely reporting of the case reports. With a choice of fully validated and compliant safety database solutions, highly effective SOPs and operating guidelines in place, thorough employee training, and a constant quality management system ‘on time’ reporting is a major priority. Reports may be made electronically or by hard copy as required by the applicable regulations.
System establishment, PV-QMS & procedural development activities
Safety data collection, evaluation, understanding and prevention of ADRs/AEs
Development & submission of periodic safety writing reports
Global/Local Literature searching followed by classification
Queries (Call/Email) Receipt & Resolution Management
PharmaVigil is equipped with fully supported and regulatory compliant safety database solutions.
Quality and Compliance are highest priorities for us while handling drug safety and other activities.
Development & submission of PSMF/PSSF, PvMF & PSMF summary as part of module 1.8.2
RMP/REMS Risk identification followed by development of plan