What NAFDAC requires, whichever model you choose
The choice between models does not change the requirements. Under the NAFDAC Good Pharmacovigilance Practice Guidelines, the QPPV must:
- Reside and operate in Nigeria
- Be at the company's disposal permanently and continuously
- Have documented back-up arrangements, with a deputy who holds the information needed to act
- Have authority over the pharmacovigilance system and the Pharmacovigilance System Master File
- Be able to access safety data at any time, including outside working hours
- Act as NAFDAC's single pharmacovigilance contact point on a 24-hour basis
Our guide to the QPPV in Nigeria covers each requirement in detail. The question here is only who fills the role.
Is an outsourced QPPV allowed in Nigeria?
Yes. NAFDAC's guidelines state that a Certificate of Registration Holder may subcontract activities of its pharmacovigilance system to another organisation or person, and that this may include the role of the QPPV. They also note that the QPPV details aligned to a product may be those of a contract QPPV rather than one employed directly, and that one QPPV may serve more than one company provided all obligations can be met.
The same guidelines are equally clear about the limit. The company retains full responsibility for the completeness and accuracy of the master file, and ultimate responsibility for all pharmacovigilance tasks and for the quality and integrity of the system always stays with the Certificate of Registration Holder.
In-house and outsourced QPPV compared
| Factor | In-house QPPV | Outsourced QPPV |
|---|---|---|
| Regulatory accountability | Stays with the company. | Stays with the company. Outsourcing never transfers it. |
| Residency in Nigeria | Requires a Nigeria-based employee. | Provided by a Nigeria-based service provider. |
| Deputy cover | The company must recruit and train a second person. | Usually included in the service, if the contract says so. |
| Continuity | At risk when the QPPV resigns, travels or goes on leave. | The provider carries the continuity risk, subject to the contract. |
| Depth of expertise | Depends on one individual. | Draws on a team with experience across products and inspections. |
| Product knowledge | Close daily knowledge of the company's products. | Must be built through onboarding and regular data flow. |
| Cost drivers | Salary, benefits, training, systems and a deputy. | Service fee, scaled to portfolio size and scope. |
| Speed to set up | Recruitment can take months. | Usually faster, because the provider already has the people and processes. |
| Oversight the company must run | Line management and performance review. | Contract management, vendor audits and reconciliation. |
When an in-house QPPV makes sense
- Your Nigerian portfolio is large enough to justify a full-time safety role
- You already run a Nigerian safety team or safety database
- Your products carry a high safety workload, such as new molecules, biologicals or vaccines
- You want the QPPV embedded in local commercial, medical and regulatory decisions every day
- You can recruit and keep both a qualified QPPV and a trained deputy in Nigeria
The main weakness of the in-house model is concentration. If the safety system depends on one employee and that person leaves without a trained deputy, the company can find itself without a compliant QPPV overnight.
When an outsourced QPPV makes sense
- You are a foreign manufacturer with a global safety function but no team in Nigeria
- Your Nigerian portfolio is small or mostly established products
- You are entering the Nigerian market and need cover from the first day of registration
- Your current QPPV has left, or is based outside Nigeria
- You want deputy cover and inspection experience without building them yourself
- You import or distribute several brands and need one consistent safety system
The main weakness of the outsourced model is distance. A provider can only oversee what it is told about, so the company must send safety information promptly and keep the provider involved in decisions that affect the system.
The hybrid model
Many multinationals use a hybrid. The global safety department keeps case processing, the safety database and aggregate reports, while a Nigerian partner provides the resident QPPV and deputy, local case intake, Nigerian literature monitoring and NAFDAC liaison. This model works when the split of responsibilities is written down precisely and both sides reconcile their data regularly. Without that, cases fall between the two.
What NAFDAC requires when you outsource
NAFDAC's guidelines set specific conditions for any subcontracted pharmacovigilance work, including the QPPV role:
- A detailed, current written contract that describes what is delegated and each party's responsibilities
- Detailed descriptions of the delegated tasks, the interactions and data exchange, agreed definitions, tools, assignments and timelines
- Clear arrangements for running pharmacovigilance day to day, including maintenance of any safety database
- A way to check, on an ongoing basis, that the arrangement is being followed, with risk-based audits of the provider recommended
- A description of the delegated services in the Pharmacovigilance System Master File, and the contract listed in its annex
- Where the QPPV is employed by a third party, this shown in the master file together with the provider's name
The provider may itself be inspected at NAFDAC's discretion, and all of NAFDAC's pharmacovigilance guidance applies to it as it does to the company.
What a QPPV service agreement must contain
Use this checklist to review any QPPV contract before signing.
QPPV service agreement checklist
- The named QPPV and named deputy, both resident in Nigeria
- The products covered, listed by name and registration number
- Each party's responsibilities, written task by task
- How and when the company sends safety information to the QPPV, with timelines
- Out-of-hours contact arrangements and access to the safety database
- Who maintains the Pharmacovigilance System Master File and how changes are notified
- Who submits individual case safety reports and periodic reports to NAFDAC
- Signal detection, literature monitoring and risk management responsibilities
- How NAFDAC requests and inspections are handled
- Audit rights for the company over the provider
- Confidentiality and data protection terms
- Notice periods and a handover plan if the contract ends, so cover never lapses
Our QPPV Support Essentials guidance covers oversight of an outsourced QPPV in more depth.
Download the NAFDAC QPPV Compliance ChecklistQuestions to ask a QPPV provider
- Where do your QPPV and deputy live and work?
- What pharmacovigilance and inspection experience do they have?
- How many companies does your QPPV currently cover, and how do you keep that manageable?
- How will you get to know our products?
- How do we reach the QPPV outside office hours?
- How do you handle a NAFDAC information request with a short deadline?
- Which other services can you provide alongside the QPPV role, such as case processing, signal detection and regulatory support?
- What happens to our master file and records if the contract ends?
Common mistakes with either model
- No deputy. An in-house QPPV with nobody trained to step in.
- A contract with no detail. An outsourced QPPV appointed by email, with no written split of responsibilities.
- A QPPV kept out of the loop. Safety information, acquisitions and new partnerships never reach the QPPV.
- Treating outsourcing as handing off responsibility. The company stops checking the provider's work.
- A master file that doesn't match reality. It names one model while the company runs another.
Our breakdown of GVP compliance in Nigeria covers the wider system the QPPV oversees, and our complete guide to pharmacovigilance in Nigeria sets the QPPV in context.
Frequently asked questions
Can the QPPV role be outsourced in Nigeria?
Yes. NAFDAC's guidelines allow a Certificate of Registration Holder to subcontract pharmacovigilance activities, including the QPPV role, under a detailed written contract.
Who is responsible if an outsourced QPPV makes a mistake?
The Certificate of Registration Holder. Ultimate responsibility for the pharmacovigilance system always stays with the company, whoever does the work.
Does an outsourced QPPV still need to be in Nigeria?
Yes. The residency requirement applies to every QPPV, whether employed directly or provided by a third party.
Can one QPPV cover several companies?
Yes, provided the QPPV can fulfil all obligations for each pharmacovigilance system.
Is an outsourced QPPV cheaper than an in-house one?
It often is for a small or mid-sized portfolio, because the company avoids salary, deputy, training and systems costs. For a large portfolio with a heavy safety workload, an in-house team can be more economical.
Does an outsourced QPPV need to appear in the master file?
Yes. The master file must show the QPPV's details and, if the QPPV works for a third party, the name of that company. The delegated services and the contract must also be recorded.
Can NAFDAC inspect our QPPV provider?
Yes. NAFDAC may inspect the organisation to which pharmacovigilance work is subcontracted.
What happens if we change QPPV provider?
Cover must stay continuous. Plan a handover with the outgoing and incoming providers, have the new QPPV accept responsibility in writing, and update NAFDAC and the master file.
How MedNova supports both models
MedNova Lifesciences provides outsourced QPPV and deputy cover in Nigeria, and supports companies that run their own QPPV, through its pharmacovigilance services: local case intake, case processing, signal detection, literature monitoring, master file maintenance and inspection readiness. Because we also provide regulatory affairs support and training and consulting, a company can use one partner for safety and registration. See our capability statement.
Related reading: QPPV in Nigeria, NAFDAC pharmacovigilance requirements, signal detection in pharmacovigilance, the PV Readiness Guide and the resources library.
Next step: download the NAFDAC QPPV Compliance Checklist, take the free MedNova PV Gap Assessment, or contact our team to discuss the right QPPV model for your portfolio.
Not sure which QPPV model fits your portfolio?
MedNova Lifesciences provides resident QPPV and deputy cover in Nigeria, and supports in-house QPPVs with case processing, signal detection, master file maintenance and inspection readiness.
Contact MedNova LifesciencesRelated resources
References
- National Agency for Food and Drug Administration and Control. NAFDAC Good Pharmacovigilance Practice Guidelines (Doc. Ref. PV/PMS-GDL-017-01). nafdac.gov.ng
- National Agency for Food and Drug Administration and Control. Good Pharmacovigilance Practice Regulations, 2021. nafdac.gov.ng
- National Agency for Food and Drug Administration and Control. Pharmacovigilance and Post Market Surveillance Guidelines index. Use this page to confirm the current edition of any NAFDAC document referenced above.
- MedNova Lifesciences. Pharmacovigilance services, Nigeria and Africa. mednovalife.com/pv.html
- MedNova Lifesciences. Regulatory affairs services, Nigeria and Africa. mednovalife.com/regulatory.html