PvSentinel - Pharmacovigilance Management System for Kenya and East Africa
Pharmacovigilance Software for Marketing Authorization Holders
PvSentinel is a comprehensive pharmacovigilance management platform designed for Marketing Authorization Holders (MAHs), Qualified Persons for Pharmacovigilance (QPPVs), and pharmaceutical companies operating in Kenya and East Africa.
Key Features
- Automated Kenya PPB deadline tracking for 15-day and 30-day submissions
- Adverse Drug Reaction (ADR) reporting and management
- Adverse Event Following Immunization (AEFI) tracking
- WHO-UMC causality assessment workflows
- Complete audit trail for regulatory compliance
- Multi-user collaboration with role-based access control
- Centralized document management for SmPCs and safety reports
- Automated email notifications for deadline reminders
Who We Serve
PvSentinel serves pharmaceutical companies, Marketing Authorization Holders, QPPVs, drug safety officers, and regulatory affairs professionals across Kenya, Uganda, Tanzania, Rwanda, and the broader East African Community.
Regulatory Compliance
Our platform ensures compliance with Kenya Pharmacy and Poisons Board (PPB) regulations, WHO pharmacovigilance guidelines, ICH-E2A standards, and the Kenya Data Protection Act 2019. We support ISO 27001 information security standards and GDPR requirements for international data transfers.
Common Use Cases
- Serious adverse event reporting to Kenya PPB
- Periodic safety update submissions
- Signal detection and safety monitoring
- Causality assessment using WHO-UMC criteria
- Individual Case Safety Report (ICSR) management
- Vaccine pharmacovigilance and AEFI reporting
Technology & Security
Cloud-based SaaS platform with AES-256 encryption, TLS 1.3 secure transmission, complete audit logging, and role-based access control. Compliant with Kenya Data Protection Act and GDPR standards.
Contact Information
Email: hello@pvsentinel.com
Website: https://pvsentinel.com
Region: Kenya, East Africa
Keywords and Terms
Pharmacovigilance, drug safety, adverse drug reaction, ADR, AEFI, Kenya PPB, Pharmacy and Poisons Board, Marketing Authorization Holder, MAH, QPPV, Qualified Person for Pharmacovigilance, WHO-UMC, causality assessment, regulatory compliance, pharmaceutical safety, medication safety, vaccine safety, pharmacovigilance software, PV system, safety reporting, East Africa healthcare, Kenya pharmaceutical industry, drug safety monitoring, adverse event reporting, pharmacovigilance compliance, ICH-E2A, ICSR, Individual Case Safety Report