How to Report ADRs via PvERS in Kenya
The Pharmacovigilance Electronic Reporting System (PvERS) is the PPB's official channel for submitting adverse drug reaction (ADR) reports, and every MAH and QPPV operating in Kenya is expected to be registered and actively using it.
Serious vs non-serious ADR timelines
- Serious ADRs must be reported within 15 calendar days of your team becoming aware of them
- Non-serious ADRs have a 90-day reporting window
The reporting workflow
- An ADR is identified — through direct patient/HCP report, literature monitoring, or internal signal detection
- The QPPV or delegated PV team member classifies severity
- A report is compiled, typically in CIOMS-style format
- The report is submitted through PvERS within the applicable window
- Follow-up correspondence with PPB is tracked until case closure
Where manual tracking breaks down The most common failure point isn't the reporting itself — it's the classification and escalation step, particularly for companies relying on shared inboxes or spreadsheets to flag which ADRs are "serious" and racing against a 7-day clock.
PvSentinel's automated ADR classification and deadline alerts
FAQ
Who can submit an ADR report on PvERS — only the QPPV?
Healthcare workers, MAHs, and the public can all submit; the QPPV is typically responsible for company-level submissions but isn't the only registered user type. Is there a mobile option for ADR reporting? Yes — mPvERS allows field-level and remote submission that syncs with the same national database.