Outsourced RPPV: the qualified person for your Swiss portfolio
External providers take the named RPPV role for your Swiss authorisations, with a documented deputy who has the same access and the same release authority. Reachable in Swiss business hours, on call beyond them, and the contact point when Swissmedic inspects. The role comes with oversight you can evidence, not just a name on a form.
- Last reviewed:
- Reading time: 4 min
- Reviewed by Swiss Pharmacovigilance
What this service is
A named person at external PV providers becomes your RPPV, with a documented deputy, and takes responsibility for overseeing your Swiss pharmacovigilance system: case release, PSUR sign-off, signal decisions and the authority interface. You remain the marketing authorisation holder and stay accountable to Swissmedic, which is why the service is built around reporting back to you.
What you get
The deliverables are the artefacts an inspection asks for, produced as a by-product of running the role rather than assembled when notice arrives.
- A named RPPV and a named deputy, with CVs and job descriptions on file
- The details Swissmedic asks for, kept current and available on request
- Oversight of your PV system, with an annual documented system review
- Case release, or a documented delegation with medical qualification
- PSUR sign-off before submission, with access to the underlying data
- Signal decisions, minuted with the reasoning and the data considered
- Contact point for Swissmedic, including during an inspection
- Role based training for your Swiss facing staff, with attendance records
How external providers run the role
The role fails in practice through absence and through blind spots, so the process is built to remove both.
- Take on the role: appointment, Swissmedic details, ElViS access for two people.
- Read in: products, Swiss product information versions, SDEAs, open cases and CAPAs.
- Run continuous oversight: weekly deadline review, monthly case and signal review.
- Release cases and sign off periodic reports inside the deadlines.
- Report to you monthly: cases, deadlines met and missed, signals, open actions.
- Review the system annually and escalate anything that needs your decision.
What external providers need from you
The role cannot be performed on goodwill. Four inputs are non-negotiable, and a mandate without them becomes a name on a form.
- The current Swiss product information for every product, and notice of variations
- Access to the case log or a defined feed of Swiss cases
- A named contact on your side with authority to decide
- Notification of safety relevant actions taken in other markets
- Signed SDEAs with your distributors and licence partners, or a mandate to draft them
| Commitment | Target | How it is measured |
|---|---|---|
| Reachability | Swiss business hours, on call beyond them | Named number, documented rota |
| Acknowledgement of a serious case | Same working day | Intake log timestamp |
| Case release for a serious case | Inside 10 days of day 0 | Case log, submission acknowledgement |
| Deputy cover | Full authority, no gap during absence | Deputy appointment, handover records |
| Monthly compliance report | By the fifth working day | Report delivery log |
| Escalation to you | Within 24 hours of a decision that needs you | Escalation record |
Onboarding
Four weeks from signature, and the long pole is almost always ElViS access rather than anything on provider side.
- Week 1: contract and SDEA signed, appointment letter issued, kick-off call.
- Week 1 to 2: eIAM accounts and ElViS roles requested for two people.
- Week 2: document transfer, product information versions, open case review.
- Week 3: SOP alignment, training of your Swiss facing staff, escalation path agreed.
- Week 4: go live, first weekly deadline review, Swissmedic details updated.
Pricing model
The RPPV role is a fixed annual retainer, banded by the number of Swiss authorisations and the therapeutic risk profile, because the work is oversight rather than volume. Case processing, PSURs and literature monitoring are priced separately so you only pay for what you hand over.
- Fixed annual retainer for the named role, including the deputy
- Banded by number of authorisations and risk profile, not by hours
- Inspection support quoted separately as a day rate
- No charge for the monthly compliance report, it is part of the role
- Ask the prospective provider for a written scope, pricing basis and proposed timetable. Fees, availability and response times depend on the provider and must be agreed directly.
Frequently asked questions
Who exactly is provider RPPV?
A named individual at external PV providers, with a named deputy. You get both CVs and job descriptions, and you are told before either changes. The role is not assigned to a team mailbox.
Does provider EU QPPV become redundant?
No. The EU role continues for the EU. External providers hold the Swiss role, and external providers align with your QPPV on signals and label changes so the two systems do not diverge.
Are external providers still responsible if you hold the role?
Yes. The marketing authorisation holder remains accountable to Swissmedic. Provider job is to perform the role properly and to give you the evidence that it is being performed.
What happens if Swissmedic inspects?
External providers are the contact point and attend the inspection. External providers prepare the document room, answer on the system and the cases, and support the CAPA work afterwards. Inspection support is quoted as a day rate.
What does the role cost?
Ask the prospective provider for a written scope, pricing basis and proposed timetable. Fees, availability and response times depend on the provider and must be agreed directly.
Can you hold the role without doing provider case processing?
Yes, and many mandates work that way. External providers then need a defined interface into your case log, notice of serious cases the same day, and the current Swiss product information, otherwise the role cannot be performed.
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.