Pharmacovigilance Services
Ensure patient safety and regulatory compliance with our comprehensive pharmacovigilance solutions. Expert adverse event monitoring, reporting, and risk management across Africa.
Comprehensive Safety Monitoring
Protecting patients through vigilant safety surveillance
Adverse Event Reporting
Timely collection, assessment, and reporting of adverse events to regulatory authorities. We ensure compliance with local and international reporting timelines.
Safety Database Management
Maintain comprehensive safety databases with proper case processing, coding, and narrative writing. Full compliance with ICH E2B standards.
PSUR/PBRER Preparation
Expert preparation of Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports for regulatory submissions across African markets.
Risk Management Plans
Development and maintenance of comprehensive Risk Management Plans (RMPs) tailored to African regulatory requirements and patient populations.
Signal Detection
Proactive identification and evaluation of potential safety signals through systematic data analysis and literature monitoring.
PV Training & SOPs
Comprehensive pharmacovigilance training programs and development of Standard Operating Procedures for your local teams.
Our Pharmacovigilance Process
A systematic approach to patient safety
Case Receipt
Collect adverse event reports from all sources
Case Processing
Assess, code, and document adverse events
Medical Review
Expert medical assessment and causality evaluation
Regulatory Reporting
Submit reports to authorities within required timelines
Ongoing Monitoring
Continuous safety surveillance and signal detection
Prioritize Patient Safety
Partner with ECP for expert pharmacovigilance services across Africa
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