Swiss pharmacovigilance services for authorisation holders
External providers run Swiss pharmacovigilance for marketing authorisation holders who do not have the role, the reach or the languages in house. You can take a single building block, such as the RPPV, or the whole system. What cannot be outsourced is the responsibility, and external providers build provider reporting around that fact.
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What outsourcing covers, and what stays with you
External providers can perform every operational task: the named RPPV role, case intake and submission, PSURs, literature monitoring, RMP work, audits and training. What stays with you by law is accountability to Swissmedic. That is why every service comes with reporting you can show an inspector, not just a service that runs quietly.
Three ways to work with external providers
Most mandates start narrow and grow. The three models below cover the usual entry points, and moving from one to the next does not mean re-contracting from scratch.
| Model | What is included | Who it suits | What stays with you |
|---|---|---|---|
| RPPV only | Named RPPV and deputy, system oversight, case release, PSUR sign-off, inspection contact | Holders with their own case processing but no Swiss role | Case handling, submission, literature, PSUR writing |
| RPPV plus case processing | The above plus 24/7 intake, coding, follow-up and ElViS submission | Foreign holders with no Swiss operations | Product information upkeep, commercial decisions, label variations |
| Full Swiss PV system | The above plus literature monitoring, PSURs, signal management, SDEAs and training | Holders entering Switzerland, or consolidating after an audit finding | Accountability, funding and the decisions external providers recommend |
Why a Swiss provider and not the EU team?
A capable European PV team can run Switzerland badly for entirely structural reasons. Five of them come up in almost every mandate external providers take over.
- Expectedness is assessed against the Swiss product information, not the EU SmPC
- Submission runs through ElViS, with its own access, formats and acknowledgements
- Authority correspondence happens in German, French or Italian
- Swissmedic inspects against the TPO and its own guidance, not against GVP
- Swiss business hours reachability and on-call cover have to be real, not nominal
How an engagement starts
From first contact to a live mandate is typically four weeks, most of which is document transfer rather than negotiation.
- You send the authorisation numbers, the estimated case volume and the scope you want.
- 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.
- A short call with the person who would run the mandate, not an account manager.
- Contract and SDEA, defining scope, day 0, cascade deadlines and escalation.
- Transition: system documents, product information versions, ElViS access, training.
- Go live, with a monthly compliance report from the first month.
Pricing model overview
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
Can external providers outsource only the RPPV role?
Yes, and it is the most common entry point. External providers take the named role with a documented deputy while you keep case processing in house. External providers then need a defined interface so that the role can actually be performed, in particular access to the case log and the Swiss product information versions.
Does outsourcing transfer the responsibility?
No. The marketing authorisation holder remains accountable to Swissmedic. What outsourcing transfers is the work and the operational risk, and what you get back is evidence of oversight: monthly compliance reporting, deadline statistics and documented decisions.
What does it 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.
How quickly can you start?
Typically four weeks from signature, less if a deadline is running. The critical path is usually ElViS access and the transfer of system documents, not provider internal set-up.
Can you take over from another provider?
Yes. Transitions are a normal part of the work. External providers ask for the case log, the open cases, the SDEAs, the training file and any outstanding CAPAs, and external providers reconcile case counts before external providers take responsibility.
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.