The qualified person responsible for pharmacovigilance
Every Swiss marketing authorisation holder names a qualified person responsible for pharmacovigilance, the RPPV. The role requires demonstrable pharmacovigilance knowledge and reachability during Swiss business hours with on-call cover beyond them. Residence in Switzerland is not required, but the details go to Swissmedic on request.
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- Reviewed by Swiss Pharmacovigilance
What is the RPPV?
The RPPV is the person the authorisation holder names as responsible for its Swiss pharmacovigilance system. The role is a Swiss one: an EU QPPV does not cover it, because Switzerland is not part of EudraVigilance and does not adopt EU decisions automatically. The same individual may hold both roles, but the Swiss role has to be named, documented and reachable in its own right.
Who can be an RPPV?
There is no single prescribed diploma. What has to be demonstrable is extensive pharmacovigilance knowledge: a relevant scientific or medical background, practical case processing and signal experience, and familiarity with the Swiss framework. In practice that means a CV and a job description that an inspector can read against the tasks below.
- A scientific, pharmaceutical or medical background
- Demonstrable practical pharmacovigilance experience, not only theory
- Knowledge of Swiss requirements, not only GVP
- Reachable during Swiss business hours, with on-call cover outside them
- Enough authority in the organisation to stop or change something
- No residence requirement in Switzerland, but contactability that is real
Tasks of the RPPV
The role is accountable for the system rather than for typing cases. The eight tasks below are the ones an inspection expects to see performed and evidenced by the named person or their documented delegate.
- Maintain and oversee the pharmacovigilance system, including its written description.
- Release individual case reports, or name a delegate with the medical qualification to do so.
- Sign off the periodic safety reports before submission.
- Decide in signal management: validate, escalate, close, with the reasoning recorded.
- Act as the contact point for Swissmedic, including during an inspection.
- Ensure training of every function with patient contact, and keep the records.
- Own deviations and CAPAs, including the effectiveness check.
- Keep a deputy arrangement that works in practice, not only on paper.
RPPV and QPPV compared
The two roles look alike and differ in exactly the places that matter operationally: the register you appear in, the database you submit to, and the document you assess expectedness against.
| Aspect | RPPV, Switzerland | QPPV, EU |
|---|---|---|
| Legal basis | Art. 59 TPA, Art. 61 ff. TPO | Regulation 726/2004, Directive 2001/83, GVP |
| Notified to | Swissmedic, on request | EudraVigilance registration, EMA |
| Case database | ElViS | EudraVigilance |
| Residence | Not prescribed | Must reside and operate in the EU |
| Reachability | Swiss business hours plus on-call | 24/7 contactability expected |
| Expectedness reference | Swiss product information | EU SmPC |
| Deputy | Required and documented | Required, back-up person in the PSMF |
Deputy and holiday cover
The single most common finding is not an unqualified RPPV but an absent one. A named deputy who has no ElViS access, no case release authority and no training record is not cover. Test the arrangement before an inspection does: pick a week the RPPV is away and confirm a serious case could have been released and submitted inside 15 days.
Two people, two accesses, one documented handover
Set up at least two ElViS accounts, name the deputy in the SOP, give them the same release authority and record the handover for every absence. A single point of failure in the RPPV role is a system finding, not an administrative detail.
In house or outsourced?
The decision is rarely about competence and usually about volume and coverage. A portfolio with a handful of Swiss authorisations and a few dozen cases a year cannot sustain an internal RPPV who is both experienced and reachable at short notice, which is why the role is commonly placed with a Swiss provider.
| Criterion | Points to in house | Points to outsourcing |
|---|---|---|
| Case volume | High and steady | Low or irregular |
| Number of Swiss authorisations | Large portfolio | A few products |
| Swiss presence | Own Swiss affiliate with staff | No Swiss entity or staff |
| Languages | German, French and Italian in house | Translation needed for authority contact |
| Coverage outside office hours | Own on-call rota exists | No rota, no deputy depth |
| Inspection experience | Team has been inspected before | First Swiss inspection ahead |
Frequently asked questions
Can our EU QPPV also be the Swiss RPPV?
In practice yes, and it is common. The Swiss role still has to be named separately, documented in its own right, reachable during Swiss business hours and able to submit through ElViS. What is not acceptable is treating the EU appointment as automatically covering Switzerland.
Does the RPPV have to live in Switzerland?
No. Residence is not prescribed. What is required is genuine reachability during Swiss business hours, with on-call cover beyond them, and the details have to be available to Swissmedic on request.
Does the RPPV have to be a physician?
Not necessarily. The requirement is demonstrable extensive pharmacovigilance knowledge. Medical assessment of individual cases can be delegated to a qualified physician, with the delegation documented in the SOP.
How many authorisation holders can one RPPV serve?
There is no fixed number. What matters is whether the person can actually perform the tasks for each holder, with deputy cover and without deadline conflicts. An RPPV serving many portfolios with no team behind them is a finding waiting to happen.
What happens if the RPPV leaves?
The deputy takes over, and you appoint a successor and update the documentation and the Swissmedic details without delay. A gap in the role is a gap in the system, and cases keep arriving during it.
Can the RPPV also be the responsible person for the establishment licence?
The two roles are distinct, with different legal bases and different competence requirements. One person can hold both if they meet both sets of requirements and the workload allows it, but the appointments and the responsibilities have to be documented separately.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.