Yes, potentially, for human medicines. The European Medicines Agency (EMA) and Heads of Medicines Agencies state in GVP Module I that a marketing authorisation holder may subcontract pharmacovigilance activities to a third party and that this may include the qualified person responsible for pharmacovigilance (QPPV) role. Direct employment by the marketing authorisation holder is therefore not an express condition in the EU guidance.
An employer of record arrangement still has to pass two separate tests. The marketing authorisation holder, or MAH, must create a valid QPPV appointment with the required authority, access, qualifications, location and continuous availability. The chosen EOR must also agree that its employing entity can support the regulated duties, work pattern and contract terms. Putting a drug-safety employee on an EOR's payroll answers neither test by itself.
Use a simple decision rule: appoint the person only after the regulatory relationship and the employment relationship are both confirmed in writing.
EU guidance allows a third-party QPPV
EU medicines law requires an MAH to have an appropriately qualified QPPV permanently and continuously at its disposal. The person must reside and operate in the EU and is responsible for establishing and maintaining the MAH's pharmacovigilance system.
Direct employment by the MAH is absent from that rule. The GVP guidance says subcontracting to another organisation or person may include the QPPV role.
That creates a viable path for an EOR-employed EU QPPV. It also places the arrangement inside a regulated system that needs more than an ordinary employment agreement.
Ultimate responsibility for every pharmacovigilance task and for the quality and integrity of the system stays with the MAH. GVP Module I requires the MAH to give the QPPV enough authority to influence its pharmacovigilance activities and quality system. Access must extend to the pharmacovigilance system master file, or PSMF, relevant safety information, procedures, audits and databases.
An EOR can hold the local employment relationship. It cannot absorb the MAH's regulatory accountability merely by becoming the legal employer.
The appointment and employment relationships must meet in the middle
In a conventional EOR arrangement, the EOR signs the local employment contract and administers payroll, benefits and employment compliance. The client company directs the worker's day-to-day work. Borderless describes that split in its public EOR overview.
The QPPV relationship adds a regulatory chain:
How the parties structure the service determines the exact legal form. The EOR may provide payroll and employment support while the MAH appoints the individual directly and keeps the EOR outside the pharmacovigilance function. Another structure may assign the EOR or a related service party pharmacovigilance duties. EU pharmacovigilance counsel should classify the actual arrangement. Every document then needs to tell the same story.
Where a contract actually assigns pharmacovigilance activities to a third party, current Article 6 applies. That subcontract must describe the third party's roles and responsibilities. It must also address safety-data exchange where relevant, audit and inspection arrangements, and third-party agreement to regulatory inspection. A third party needs the MAH's written consent before passing an assigned pharmacovigilance task to another party. Payroll-only support does not by itself prove that the EOR has accepted a pharmacovigilance activity.
Six conditions decide whether the candidate fits
1. The person resides and operates in the right place
Residence and actual work both need to be in the EU. EMA guidance extends this treatment to Norway, Iceland and Liechtenstein under EEA arrangements. Check the person's real residence and working location rather than the EOR's registered address.
Remote work from an ineligible country can change the answer even when the employment contract names an EU office. Travel and relocation plans also need review because the rule addresses where the QPPV resides and operates.
2. The MAH validates the person's qualifications
Before appointment, the MAH must ensure the QPPV has adequate theoretical and practical pharmacovigilance knowledge. EMA expects the assessment to cover education, knowledge of EU pharmacovigilance requirements and relevant experience.
Where the QPPV lacks the specified basic medical training, Article 10 requires assistance from a medically trained person and documentation of that support. The MAH should also train the candidate on its own pharmacovigilance system and products before the person starts in the role.
An experienced case processor, safety scientist or pharmacovigilance manager may still fall short of this standard. Operational experience and QPPV readiness are separate assessments.
3. The person has real authority and access
Sufficient authority means the QPPV can influence the MAH's quality system and pharmacovigilance activities. The duties must appear in a job description, and the hierarchical relationship must appear in an organisational chart.
In practice, the MAH needs to give the person direct routes to senior management, relevant safety data, risk-management work, audits, procedures, contracts and validated systems. The QPPV must be able to obtain urgent information outside normal working hours. A nominal title paired with limited access cannot meet that operating model.
This is often the hardest EOR question. The EOR is the legal employer, while the MAH must give the employee functional authority inside the MAH's regulated system. The employment agreement, service agreement and MAH governance documents need to support that authority without contradicting one another.
4. Continuous availability has a credible coverage design
GVP Module I makes the QPPV the single pharmacovigilance contact point for authorities on a 24-hour basis. It also requires backup procedures for the person's absence. The backup must have the information needed to fulfil the role.
Treat this as a coverage requirement. One employee should not be scheduled to work every hour. Define how calls reach the QPPV or trained backup, which events trigger escalation, who can access systems after hours, and how holidays, illness and travel are covered.
Ask the EOR to review that pattern under local employment law and reflect any standby, call-out, rest and pay terms in the employment documents.
5. The workload leaves room for system oversight
Each pharmacovigilance system can have one QPPV. EMA guidance allows one person to serve more than one MAH or system when the person can fulfil every obligation.
Review the candidate's complete load: products, territories, safety profile, studies, inspections, other QPPV mandates and operational tasks. A person who spends most of the week processing cases may lack the capacity to oversee the system, respond to authorities and act on emerging safety issues.
Specific tasks may be delegated to trained people under the QPPV's supervision. System oversight and an overview of the safety profiles of all covered products stay with the QPPV.
6. The EOR accepts the regulated assignment
Ask the chosen provider to confirm the role against its own entity, contract, insurance and risk rules. Its review should cover a named EU QPPV appointment, 24-hour contact coverage, support for the employee's regulator interaction and inspection duties, and access to sensitive safety systems. Separately identify any pharmacovigilance activities the provider itself would assume.
The public Borderless sources reviewed for this article describe general EOR employment and Irish hiring infrastructure. They do not state that Borderless accepts EU QPPV appointments or pharmacovigilance subcontracts. That capability requires a role-specific written decision. Generic healthcare coverage provides no substitute for it.
An Ireland location solves one condition
Consider a candidate who genuinely lives and performs the QPPV role in Ireland. Ireland is an EU Member State, so that fact can satisfy the residence and operating-location condition. The HPRA guidance places Irish MAHs within the same EU pharmacovigilance framework and points them to Regulation 520/2012 and GVP.
The Irish location does not settle qualification, authority, PSMF access, backup or provider acceptance. It also creates a local employment implementation question. Ireland's working-time rules generally provide for an average 48-hour maximum working week and 11 consecutive hours of daily rest. The Workplace Relations Commission's on-call example shows how a call-out can affect rest and compensatory-rest duties.
For an Irish EOR employee, the MAH and EOR should translate 24-hour regulatory contact into a backup and escalation roster that respects those employment rules. Ireland is an illustration of how regulatory availability and local employment law must work together. It is not a reason to choose Ireland over another eligible location.
Build one inspection-ready record of the arrangement
Build a written record that allows an inspector to see who appointed the person, who employs them, what they can access and how the system functions when they are unavailable.
EMA application guidance also expects the pharmacovigilance-system summary to include proof that the applicant has the QPPV at its disposal, the Member States where the person resides and works, contact details, a signed statement about the means to fulfil pharmacovigilance duties, and the PSMF location.
For an existing authorisation, update QPPV and PSMF-location information through the applicable regulatory process and Article 57 data. Keep the PSMF accurate as the employment, location, backup or contract changes.
