Case management: from intake to ElViS submission
External providers take Swiss case processing end to end: intake by phone, e-mail and web form, a defensible day 0, duplicate check, MedDRA coding, seriousness and expectedness assessment against the Swiss product information, follow-up, medical review, ElViS submission and the acknowledgement filed in your record.
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- Reviewed by Swiss Pharmacovigilance
What this service is
An operational case processing service for the Swiss part of your portfolio, run to your SOPs or to ours, with a monthly compliance report. The point of the service is not typing: it is that day 0 is recorded from the source document and the 15 day deadline is met with room to spare.
What you get
Eight deliverables, all of them evidenced. The last one is the one clients notice most in an inspection.
- Intake by telephone, e-mail and web form, with out of hours cover
- Day 0 recorded from the source document, with the source retained
- Duplicate check against the existing case log
- MedDRA coding of the reaction and the medical history
- Seriousness and expectedness assessment against the Swiss product information
- Documented follow-up, with at least two targeted attempts
- Medical review and release by a qualified person
- ElViS submission and the acknowledgement filed in the case record
How external providers run it
The process is deliberately boring and identical for every case, because variability is where deadlines are lost.
- Intake: log source, date and time, and capture the minimum information.
- Triage: serious or not, duplicate or new, and set the deadline clock from day 0.
- Process: code in MedDRA, assess expectedness against the Swiss text, assess causality.
- Follow-up: ask the specific missing questions, and record every attempt.
- Review and release: medical review, then release by the RPPV or a named delegate.
- Submit through ElViS and file the acknowledgement.
- Report monthly: volumes, deadline performance, open follow-ups, trends.
What external providers need from you
- The current Swiss product information, and notice when it changes
- A forwarding rule for your field force and medical information, with provider address
- SDEAs with distributors, so their cases reach external providers inside a day
- A named medical contact for questions external providers cannot resolve
- Your case log history, if external providers are taking over from another provider
| Commitment | Target | How it is measured |
|---|---|---|
| Intake availability | 24/7 for serious cases, business hours otherwise | Intake log timestamps |
| Day 0 recording | Within one working day of receipt | Case log against the source document |
| Serious case submitted | Inside 12 days of day 0, against a 15 day limit | ElViS acknowledgement date |
| Non-serious case submitted | Inside 45 days of day 0, against a 60 day limit | ElViS acknowledgement date |
| Follow-up attempts | At least two documented, targeted attempts | Case file |
| Monthly compliance report | By the fifth working day | Report delivery log |
Onboarding
- Week 1: contract and SDEA, intake channels set up, provider address communicated.
- Week 2: ElViS access, product information versions loaded, SOP alignment.
- Week 3: train your field force and medical information on the 24 hour rule.
- Week 4: go live, with a parallel run on open cases if you are transitioning.
- Month 2: first full monthly report and a review of the deadline statistics.
Pricing model
Case processing is priced per case, banded by annual volume, with a small base fee covering the 24/7 intake availability. Follow-up and literature cases are included in the per-case price. Transition work on an existing case log is quoted separately as a day rate.
Frequently asked questions
What does 24/7 actually mean?
A reachable number and a monitored inbox for serious cases outside office hours, with a named on-call rota. Non-serious cases are handled in business hours. The rota is documented, which matters because a two day device deadline runs over a weekend.
Do you use provider safety database or yours?
Either. External providers work in your system if you give external providers access, which keeps one source of truth, or in ours and deliver the case data and acknowledgements to you. The choice affects the price only marginally.
Who releases the cases?
The RPPV or a named delegate with the medical qualification, as documented in the SOP. If external providers also hold your RPPV role, release sits with external providers; if not, external providers prepare and you release.
What does case processing 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.
Are external providers still responsible for late cases?
You remain accountable to Swissmedic. Provider service levels are set inside the regulatory deadlines precisely so that a normal delay does not become a breach, and the monthly report shows you where you stand.
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.