PV System Setup & Compliance
Development of Pharmacovigilance System Master File (PSMF)
Establishment of Local Safety Officer (LSO) and country-specific PV roles
Development of PV policies, SOPs, and quality systems
PV training for MAHs, distributors, and local partners
Compliance alignment with global and country-specific PV regulations
Individual Case Safety Reports (ICSR) Management-Uganda
Adverse event case intake, validation, and triage
Medical review and clinical assessment
Causality assessment and case processing
Timely submission of safety reports to regulatory authorities
Signal Detection & Risk Management
Safety signal identification and evaluation
Risk assessment reports and benefit-risk evaluation support
Risk Management Plan (RMP) development and updates
CAPA development for identified safety issues
Aggregate Reporting & Compliance
Preparation and submission of PSUR/PBRER
Periodic safety reporting readiness and compliance support
PV audit readiness and inspection support
Regional Pharmacovigilance Oversight
Centralized PV coordination across multiple African markets
Multi-country safety data harmonization
Regional PV compliance monitoring dashboards and reporting systems
A fully integrated pharmacovigilance framework ensuring continuous safety monitoring, regulatory compliance, and proactive risk management across product lifecycles.