PharmaVigil offers Medical Information System management for our clients by providing quality medical information service to the enquirers (HCPs and patients) by ensuring all enquiries receive accurate and medically sound responses, whilst meeting regulatory and legal requirements.
With a team of experienced healthcare professionals dedicated to patient safety and customer service, PharmaVigil can offer a flexible, integrated, Medical Information service, tailored to our clients’ specific requirements.
As experienced pharmacovigilance professionals, the medical information team is fully trained in handling adverse event reporting to the authorities. PharmaVigil is equipped to conduct case follow-up and even full case processing on your behalf.
PharmaVigil conducts timely reconciliation activities to ensure all adverse events & product quality complaints have been processed timely and correctly in-line with the applicable procedures.
PharmaVigil has been partnered with a solution provider for medical information query management system which is a validated system and fully regulatory compliant.
The medical information query management system is fully integrated with the pharmacovigilance system for efficient handling and processing of adverse events.
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