A vacant or under-resourced QPPV role creates direct regulatory exposure. Jeyflex provides experienced, dedicated Qualified Persons for Pharmacovigilance across African markets — ensuring your safety systems remain compliant, inspection-ready, and focused on patient safety at all times.
QPPV Services Across Africa
Is Your QPPV Role Vacant, Understaffed, or Stretched Across Too Many Markets?
What is a Qualified Person for Pharmacovigilance (QPPV)?
A Qualified Person for Pharmacovigilance (QPPV) is the individual legally responsible for overseeing a company’s pharmacovigilance system — including adverse event reporting, signal management, regulatory communication, and inspection readiness. They serve as the primary point of contact between the Marketing Authorization Holder (MAH) and the relevant regulatory authority regarding the safety of medicinal products.
Jeyflex provides dedicated, experienced QPPVs who take full responsibility for your PV obligations — so the role is never vacant, never stretched, and never a compliance risk.
QPPV Responsibilities Jeyflex Manages on Your Behalf
When appointed as your QPPV, our team takes full ownership of the following obligations — so nothing falls through the gaps.
01
Pharmacovigilance System Oversight
Establishment and ongoing maintenance of your pharmacovigilance system, ensuring all activities meet local and international regulatory standards.
02
Adverse Event & ICSR Management
Oversight of adverse event reporting activities and Individual Case Safety Report (ICSR) management — ensuring timely, accurate submissions to the relevant regulatory authority.
03
Signal Detection & Risk Management
Signal detection and signal management activities, alongside Risk Management Plan (RMP) implementation and benefit-risk evaluation support.
04
PSUR & PSMF Management
Coordination and submission of Periodic Safety Update Reports (PSURs) and maintenance of the Pharmacovigilance System Master File (PSMF) — kept current and inspection-ready at all times.
05
Regulatory Authority Communication
Designated point of contact for all health authority communication — including safety inquiries, benefit-risk evaluations, inspection notifications, and regulatory requests.
06
Inspection & Audit Readiness
Acting as the liaison point for pharmacovigilance audits and inspections — maintaining the documentation, SOPs, and compliance records required for a clean inspection outcome.
Why Choose Jeyflex for QPPV Services?
Our QPPV Appointment Process
Our structured approach ensures your pharmacovigilance system is compliant and your QPPV obligation is fulfilled without delay.
Benefits of Outsourcing Your QPPV to Jeyflex
Many pharmaceutical companies choose to outsource their QPPV responsibilities to specialised providers. Outsourcing to Jeyflex means:
Outsourcing allows your organisation to focus on core business activities while ensuring pharmacovigilance obligations are managed by qualified, experienced experts.
QPPV Services Across African Markets
We provide dedicated QPPV and Local Safety Officer services across East, West, North and Southern Africa — with each appointment handled by a professional who knows the specific regulatory authority and local requirements of that market.
🇳🇬 Nigeria
NAFDAC · QPPV & LSO services
🇬🇭 Ghana
FDA Ghana · QPPV services
🇿🇦 South Africa
SAHPRA · Full QPPV support
🇪🇬 Egypt
EDA · QPPV & compliance
🇸🇳 Senegal
DPM · Safety oversight
🇧🇫 Burkina Faso
LNSP · QPPV support
🇬🇲 Gambia
MHRA Gambia · LSO services
🇨🇮 Ivory Coast
DPM · ADR oversight
🇬🇦 Gabon
ANPGM · PV compliance
🇹🇳 Tunisia
DPHM · Safety compliance
Frequently Asked Questions
A QPPV is the individual legally responsible for overseeing a company’s pharmacovigilance system — including case processing, signal management, regulatory reporting, and inspection readiness. They serve as the primary point of contact between the Marketing Authorization Holder and the relevant regulatory authority for all safety-related matters.
A QPPV is the senior individual responsible for the overall pharmacovigilance system. A Local Person for Pharmacovigilance (LPPV) or Local Country Person for Pharmacovigilance (LCPPV) is appointed at the country level to manage local PV operations and liaise with the national regulatory authority. A Local Safety Officer (LSO) fulfils a similar local role depending on the regulatory framework of the specific country. Jeyflex provides all three services across African markets.
Requirements vary by country. Several African regulatory authorities, including Kenya’s PPB and Uganda’s NDA, formally require the appointment of a designated local pharmacovigilance contact. As regulatory frameworks across Africa continue to strengthen, QPPV and LPPV requirements are becoming increasingly formalised. Jeyflex advises clients on the specific requirements for each target market.
Yes. One of Jeyflex’s core strengths is managing QPPV and local pharmacovigilance obligations across multiple African markets simultaneously — with a coordinated network of local professionals and consolidated reporting, reducing the complexity and overhead of managing multiple local vendors.
Appointment timelines depend on the specific country and the documentation required by the relevant regulatory authority. Jeyflex typically begins with a rapid initial assessment of your current system and regulatory obligations, followed by formal QPPV appointment as quickly as the process permits — ensuring no gap in compliance during the transition.
Need a Qualified Person for Pharmacovigilance?
Whether you require a local QPPV, support with pharmacovigilance system setup, regulatory compliance assistance, or ongoing safety oversight across multiple African markets, our experienced team is ready to help.
[email protected] | +254 798 725 500