Pharmacovigilance Services
Technology-driven pharmacovigilance for safer, compliant, and more efficient drug safety monitoring.
Overview
At SafeVig, we recognize the paramount importance of ensuring patient safety and maintaining stringent regulatory compliance throughout the lifecycle of pharmaceutical products. Our comprehensive Pharmacovigilance (PV) Services are enhanced by SafeVig Solutions, our suite of cutting-edge technology platforms that streamline, automate, and optimize the pharmacovigilance process. Through the integration of AI, Machine Learning, Automation, and Blockchain, SafeVig delivers a seamless, efficient, and highly compliant service experience.
Case Management & Safety Reporting
- Adverse Event (AE) Case Intake & Triage: Automated capture and categorization of adverse events from trials, patient reports, and healthcare providers in real time.
- Case Processing & Data Entry: AI-powered automation ensures accurate case data logging and readiness for regulatory reporting.
- Regulatory Reporting: Generates ICSRs in compliance with FDA, EMA, and other global authorities for timely submissions.
Signal Detection & Risk Assessment
- Signal Detection: AI-driven analysis of large datasets for emerging safety trends and rapid signal identification.
- Risk Management: Continuous benefit-risk profile evaluation with real-time analytics for proactive safety action.
Post-Marketing Surveillance
- Ongoing Safety Monitoring: Real-time monitoring with automated alerts from global databases for any safety changes or risks.
- Periodic Safety Update Reports (PSURs): Automated, compliant PSUR generation to reduce manual effort and reporting time.
- Benefit-Risk Assessment: AI-based tools offer actionable, continuous safety insights.
Regulatory Compliance & Reporting
- Global Regulatory Submissions: Streamlined, timely, and accurate submissions (ICSRs, PSURs, aggregates) for global compliance.
- Audits and Inspections: Complete audit trails, inspection readiness, and data accessibility for all safety reports.
Training & Consultation
- Pharmacovigilance Training: Platform training, best practices, and regulatory requirements for PV professionals.
- Consultation Services: Expert guidance to implement and optimize SafeVig Solutions for efficiency, compliance, and reporting.
Why Choose SafeVig for Pharmacovigilance?
- Integrated Technology for Efficiency: AI-driven, automated solutions accelerate and streamline all PV processes.
- Expertise & Global Compliance: Compliance with FDA, EMA, WHO, and local/global guidelines.
- Scalability & Flexibility: Solutions tailored for startups to global pharma leaders.
- Real-Time Insights & Analytics: Proactive risk management with advanced analytics and continuous safety monitoring.
