Provision of Local Contact Persons for Pharmacovigilance/Safety Officer (LCPPV/LSO) and Deputies
Ensuring local representation for pharmacovigilance with designated safety officers and deputies, providing in-country expertise and compliance.
Provision of EAEU and Local Qualified Persons For Pharmacovigilance (LQPPV) and Deputies
Appointing qualified local and EAEU pharmacovigilance professionals and deputies to ensure regulatory alignment and local expertise. EAEU QPPV should reside and work in one of the EAEU Member states.
Development and Maintenance of Local and Regional PSMF
Creation and upkeep of local and regional Pharmacovigilance System Master Files (PSMF), documenting safety processes and ensuring regulatory adherence.
Local Literature Screening
Ongoing monitoring of local scientific literature to identify potential safety issues and emerging risks relevant to product safety.
Local PV Regulatory Intelligence
Regular tracking and analysis of pharmacovigilance regulations and legislative changes both globally and locally to maintain compliance.
Comprehensive Safety Report Management: Collection, Processing, Reporting, and Tracking
End-to-end management of safety reports, including collection, processing, regulatory reporting, and ongoing tracking to ensure patient safety and diligent case handling.
Processing of Domestic and Foreign ICSRs and Reporting to National Competent Authorities
Management of Individual Case Safety Reports (ICSRs) for both domestic and international cases, with timely reporting to relevant authorities.
Local Adaptation and Submission of Aggregate Reports (PSUR, DSUR, PBRER)
Customization and submission of periodic safety reports, including PSUR, DSUR, and PBRER, in line with local regulatory requirements.
Local Safety Notifications / Signals Management
Monitoring and assessment of safety signals, with notifications to national authorities when necessary to ensure proactive risk management.
Benefit-risk management
Benefit-Risk Assessment is a critical component of pharmacovigilance, focusing on evaluating the positive therapeutic effects of a medicinal product against its potential risks. This process involves continuous monitoring and analysis throughout the product’s lifecycle to ensure that the benefits to patients consistently outweigh any associated risks. By systematically assessing safety data, implementing risk minimization measures, and updating risk management plans, organizations can maintain a favorable benefit-risk profile, thereby safeguarding patient health and ensuring regulatory compliance.
Handling of Requests and Inspections from National Competent Authorities
Support for regulatory inspections and response to authority requests, ensuring continues compliance and readiness for evaluations.
Assurance of 24/7 Availability
Round-the-clock availability of pharmacovigilance support to handle urgent safety concerns and ensure continuous compliance.
