Pharmacovigilance without the panic
From case intake to AI-powered signal detection—built for LTRs and MAHs who need compliance to be calm, not chaotic.
The real cost of not knowing
Compliance failures can trigger immediate import freezes and heavy regulatory fines from the PPB.
Missed deadlines
Serious adverse events discovered too late. Submission windows closed before you knew they existed.
Documentation chaos
Case files scattered across emails and spreadsheets. Auditors arrive and you scramble.
Team blindspots
Your pharmacist updated a case. Your QPPV had no idea. Communication gaps become compliance risks.
What if every deadline was visible, every case traceable, every team member aligned—before it became urgent?
How PvSentinel keeps you ahead
Everything a QPPV, MAH, or LTR needs to run pharmacovigilance end to end — one platform, from intake to signal detection.
No more spreadsheets, just compliance. Nothing catches you off guard.
PvSentinel delivers calm, control, and credibility to LTRs and MAHs managing pharmacovigilance compliance.
See it in action
One workflow for every report type
ICSR, AEFI, and PQC intake share a single guided workflow from entry to submission—no separate forms to maintain.
All Cases
ICSR, AEFI, and PQC — one guided workflow from entry to submission.
PV-2026-0158
Amoxiclav 625mg
PV-2026-0155
Measles-Rubella Vaccine
PV-2026-0149
Metformin 500mg
PV-2026-0142
Ceftriaxone 1g
Every report type, one guided path from entry to submission—no separate forms to maintain.
Never miss a regulatory deadline
Automatic Kenya PPB compliance. 7-day serious, 30-day non-serious. Color-coded urgency. Always visible.
Regulatory Deadlines
3 cases require attention before their PPB submission window closes.
PV-2026-0158
Received Jan 19, 2026
Status
In Assessment
Assigned to
Clinical Team
PV-2026-0142
Received Jan 27, 2026
PV-2026-0135
Received Jan 19, 2026
All deadlines visible. No surprises ahead.
Evidence-based decisions
WHO-UMC compliant. Real-time scoring. No subjective guesswork. Just defensible, traceable assessments.
WHO-UMC Causality Assessment
Real-time guided evaluation
Did the adverse event occur in a plausible time relationship?
Could the event be explained by concurrent disease or other drugs?
Did the reaction improve when drug was discontinued?
Did the reaction reappear when drug was re-administered?
Real-time assessment
Possible
Score: 5/12 · calculated as you answer
Complete transparency
Every action logged. Every change tracked. When auditors arrive, you show proof—not explanations.
Complete Audit Trail
Every action, always traceable
Approved causality assessment
Updated assessment notes
Submitted PPB report
Complete transparency: every team action is logged with timestamp, user, and detail—ready for any audit.
Recalls tracked to zero
Every distributor and pharmacy acknowledgment logged automatically, with reminders and escalations built in.
Distribution & Recall
3 active recalls across your distribution network.
Amoxiclav 625mg
BN-2025-114
Metformin 500mg
BN-2025-098
Ceftriaxone 1g
BN-2025-076
Escalations handled, not chased: reminders go out automatically until every recipient responds.
One workflow for every report type
ICSR, AEFI, and PQC intake share a single guided workflow from entry to submission—no separate forms to maintain.
All Cases
ICSR, AEFI, and PQC — one guided workflow from entry to submission.
PV-2026-0158
Amoxiclav 625mg
PV-2026-0155
Measles-Rubella Vaccine
PV-2026-0149
Metformin 500mg
PV-2026-0142
Ceftriaxone 1g
Every report type, one guided path from entry to submission—no separate forms to maintain.
Never miss a regulatory deadline
Automatic Kenya PPB compliance. 7-day serious, 30-day non-serious. Color-coded urgency. Always visible.
Regulatory Deadlines
3 cases require attention before their PPB submission window closes.
PV-2026-0158
Received Jan 19, 2026
Status
In Assessment
Assigned to
Clinical Team
PV-2026-0142
Received Jan 27, 2026
PV-2026-0135
Received Jan 19, 2026
All deadlines visible. No surprises ahead.
Evidence-based decisions
WHO-UMC compliant. Real-time scoring. No subjective guesswork. Just defensible, traceable assessments.
WHO-UMC Causality Assessment
Real-time guided evaluation
Did the adverse event occur in a plausible time relationship?
Could the event be explained by concurrent disease or other drugs?
Did the reaction improve when drug was discontinued?
Did the reaction reappear when drug was re-administered?
Real-time assessment
Possible
Score: 5/12 · calculated as you answer
Complete transparency
Every action logged. Every change tracked. When auditors arrive, you show proof—not explanations.
Complete Audit Trail
Every action, always traceable
Approved causality assessment
Updated assessment notes
Submitted PPB report
Complete transparency: every team action is logged with timestamp, user, and detail—ready for any audit.
Recalls tracked to zero
Every distributor and pharmacy acknowledgment logged automatically, with reminders and escalations built in.
Distribution & Recall
3 active recalls across your distribution network.
Amoxiclav 625mg
BN-2025-114
Metformin 500mg
BN-2025-098
Ceftriaxone 1g
BN-2025-076
Escalations handled, not chased: reminders go out automatically until every recipient responds.
Ready to take control?
Book a Demo. We'll set up your secure environment and guide your team through onboarding.