Фармаконадзор | Агентство "Фармкомплаенс"


Based on our experience in the pharmaceutical industry, we have identified special needs for the often overworked pharmacovigilance department. What we were missing, for example, urgent assistance with the processing of a sudden high volume of messages, reconciliation of the risk management plan translation, assessment of the need for changes in processes due to the release of a new law. Learn more about “unique” services you can find below.

Standard services:
  • Full outsourcing of the pharmacovigilance system. Outsourcing of individual pharmacovigilance processes
  • Organization of a pharmacovigilance system from scratch and maintenance of the existing one. Building a quality management system and ensuring its effectiveness
  • Daily screening of legislation. Provision of regular reviews
  • Provision of qualified staff – pharmacovigilance authorized persons (PPA/QPPV), their deputies, contact persons, pharmacovigilance specialists and managers with 24/7 access
  • Organization/provision a single round-the-clock contact center for receiving complaints on the safety of medicines
  • Pharmacovigilance consulting services
  • Weekly monitoring of literature for information on the safety of medicines. Evaluation of information, provision to competent authorities
  • Collecting, processing, analyzing, storing and submitting individual case safety reports to competent authorities
  • Interaction with competent authorities, including preparing responses to requests
  • Signal management
  • Safety communications (DHPC, etc.)
Unique services:
  • Providing immediate support for entering large volumes of individual reports into the security database (including translation into English) and filing reports with the competent authorities
  • Detailed analysis of new legislation and preparation for based on Impact Assessments/Gap Analysis for each specific client pharmacovigilance system
  • Entering safety information into databases (Argus, ARISg, Flex, etc.)
  • English-Russian translations/verification of translations of safety reports and other pharmacovigilance documentation
  • Evaluation and coordination of organized data collection projects – websites, market research, hotlines, patient support programs
  • Organization of safety monitoring unregistered medicinal products (expanded access programs, provision of medical care for vital indications)
  • Organization of pharmacovigilance processes in the framework of non-interventional studies (channel ol, Safety Management Plan)
  • Assistance in managing the staff of the pharmacovigilance department. Identifying ways to streamline processes and improve their efficiency
  • Developing solutions to meet data privacy laws in the context of security reporting management