Pharmacovigilance (PV) Services
Ensuring patient safety through comprehensive pharmacovigilance systems, expert consultation, and regulatory compliance support.
URGENT: PPB QPPV Nomination Deadline
Final Deadline: December 31, 2025
All Marketing Authorization Holders (MAHs) must submit details of their nominated Qualified Person for Pharmacovigilance (QPPV) by this date.
Consequences of Non-Compliance:
- Non-retention of Health Products & Technologies (HPT) registration
- Ineligibility for product re-registration
- Non-issuance of manufacturing and wholesale dealer license for 2026
- Other appropriate regulatory actions by the Pharmacy and Poisons Board (PPB)
Reference: PPB/PDS/VMS/LET/132 dated 15th August 2025
Safeguarding Patient Health Through Vigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems. A robust PV system is essential for protecting public health and maintaining regulatory compliance in Kenya's pharmaceutical sector.
- Regulatory Compliance: Meet PPB requirements for QPPV nomination and ongoing PV obligations.
- Patient Safety: Continuous monitoring and rapid response to adverse drug reactions (ADRs).
- Risk Mitigation: Proactive identification and management of product safety risks.
- Reputation Management: Demonstrate commitment to product quality and consumer safety.
Meet Our PV Expert
Jael Morangi
Qualified Person for Pharmacovigilance (QPPV)
With extensive experience in pharmaceutical safety and regulatory compliance, Jael provides expert guidance on all aspects of pharmacovigilance for pharmaceutical companies operating in Kenya.
Areas of Expertise:
- ✓ PV System Setup & Implementation
- ✓ QPPV Nomination & Regulatory Compliance
- ✓ ADR Reporting & Signal Detection
- ✓ PV Training & Capacity Building
- ✓ PV Audits & Gap Analysis
Our Pharmacovigilance Services
Comprehensive PV support tailored to your business needs
PV System Setup
Establish a comprehensive pharmacovigilance system from the ground up, including SOPs, reporting mechanisms, and documentation frameworks.
QPPV Nomination Support
Expert assistance with QPPV nomination process, documentation, and submission to the Pharmacy and Poisons Board (PPB).
Staff Training
Comprehensive training programs on PV principles, ADR reporting, signal detection, and regulatory requirements for your team.
PV Audits
Thorough audits of your existing PV system to identify gaps, ensure compliance, and provide actionable recommendations for improvement.
ADR Case Processing
Expert support in adverse drug reaction case intake, assessment, documentation, and reporting to regulatory authorities.
Ongoing Consultation
Continuous expert advice and support to maintain and optimize your PV system as regulations and best practices evolve.
What Our Pharmacovigilance Service Covers
The full set of deliverables we provide, from QPPV hosting to inspection readiness
QPPV Nomination and Hosting
We provide a named Qualified Person for Pharmacovigilance, accepted by the PPB, who acts as your in-country safety lead. Your products stay compliant without you hiring a full-time pharmacist.
PSMF Build and Maintenance
We build your Pharmacovigilance System Master File (PSMF) from scratch and keep it current as your products, processes, and partners change.
ICSR / ADR Case Management
We handle intake, processing, and follow-up of individual case safety reports, with expedited reporting to the PPB within the required timelines.
Periodic Safety Reports (PSUR / PBRER)
We prepare and submit Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports on the schedule set in each product's conditions of approval.
Signal Detection and Management
We review your safety data regularly to spot emerging patterns, then assess, prioritise, and act on potential signals before they become safety issues.
Risk Management Plans (RMPs)
We draft product-specific Risk Management Plans and design practical risk minimisation measures that regulators accept and your teams can actually implement.
Literature Screening and Monitoring
We screen scientific and medical literature on a defined schedule for adverse events and safety information relevant to your products, and feed findings into your safety database.
PV Audits and Inspection Readiness
We audit your pharmacovigilance system against PPB expectations, close the gaps, and prepare your team and documentation so a regulatory inspection holds no surprises.
Post-Market Surveillance for Medical Devices
We run post-market surveillance for medical devices, including complaint handling, vigilance reporting, and field safety corrective actions when a device issue needs fixing in the market.
PV Training for Client Teams
We train your staff to recognise, document, and escalate adverse events correctly, so vigilance becomes part of everyday practice rather than a once-a-year exercise.
Why a Robust PV System Matters
Beyond compliance, building trust and protecting lives
Enhanced Patient Safety
Early detection and rapid response to adverse drug reactions protects patients and saves lives.
Regulatory Compliance
Meet PPB requirements and maintain your licenses, registrations, and market authorization.
Reputation & Trust
Demonstrate your commitment to quality and safety, building trust with healthcare providers and patients.
Risk Management
Proactively identify and mitigate product safety risks before they escalate into major issues.
Assess Your PV System
Use this interactive checklist to identify gaps in your current pharmacovigilance system
Need help with any of these areas? Our PV expert, Jael Morangi, can conduct a comprehensive gap analysis and provide tailored solutions to strengthen your pharmacovigilance system.
Request a PV System AssessmentQPPV & Pharmacovigilance FAQs
The most common questions pharmaceutical companies in Kenya ask about QPPV and PV requirements.
What is a Qualified Person for Pharmacovigilance (QPPV) and do I need one in Kenya?
A QPPV is a qualified pharmacist responsible for the establishment and maintenance of a company's pharmacovigilance system. Under the Pharmacy and Poisons Board (PPB) Kenya guidelines, every Marketing Authorisation Holder (MAH) for a registered pharmaceutical product in Kenya must nominate a QPPV who is a registered Kenyan pharmacist and is reachable 24/7. Non-compliance can result in product registration suspension or refusal of renewal.
Can my foreign headquarters QPPV cover the Kenya requirement?
No. PPB requires a Kenya-based QPPV nominated to the local Marketing Authorisation. Your global QPPV can remain the overall safety lead, but a designated Kenyan QPPV is mandatory for local ICSR intake, PPB correspondence, and on-site pharmacovigilance audits. We provide qualified QPPV-as-a-service on a monthly retainer.
How do I set up a pharmacovigilance system in Kenya from scratch?
A PPB-compliant PV system requires: (1) a nominated QPPV; (2) a Pharmacovigilance System Master File (PSMF); (3) PV SOPs covering ADR intake, signal detection, literature monitoring and PSUR preparation; (4) a Risk Management Plan template per product; (5) staff trained in PV workflows; and (6) PvERS account registration. Typical setup takes 6 to 10 weeks.
How are ADRs reported to PPB in Kenya?
Adverse Drug Reactions are reported via PPB's Pharmacovigilance Electronic Reporting System (PvERS). Serious ADRs must be reported within 15 calendar days; non-serious within 90 days. We also provide a free ADR report generator that produces a CIOMS-style form you can forward to PvERS.
How often must PSURs be submitted to PPB?
Periodic Safety Update Reports (PSURs / PBRERs per ICH E2C(R2)) are typically required 6-monthly for the first 2 years after authorisation, annually for years 3 to 5, then every 3 years. Exact frequency is set in each product's conditions of approval. Our free PSUR checklist tracks every section.
What happens if I don't comply with PPB pharmacovigilance requirements?
PPB can suspend or revoke product registrations, refuse renewal applications, and pursue enforcement action against non-compliant MAHs. Beyond regulatory risk, an inadequate PV system exposes the company to liability from unreported adverse events and reputational damage in the event of a safety incident.
What does QPPV nomination cost in Kenya?
We offer QPPV-as-a-service from KES 40,000 per month on a 12-month retainer. The package includes 24/7 ADR intake, ICSR submission to PvERS, monthly signal detection review, and PPB audit representation. See full PV pricing for all tiers.
Ready to Strengthen Your Pharmacovigilance System?
Don't wait until the deadline. Contact us today for expert PV support and ensure your compliance with PPB requirements.
⏰ Time-sensitive compliance support available · Expert QPPV guidance · Complete PV system setup