Your Pharmacovigilance Expert in Switzerland
We offer comprehensive services for Swiss pharmacovigilance activities, and more!
Our Services
Swiss QPPV
We provide your company with a Swiss qualified person responsible for pharmacovigilance (QPPV), a legal requirement for pharmaceutical companies operating in Switzerland.
System Oversight
We help you setup and optimize your pharmacovigilance system and standard operating procedures (SOPs) in compliance with Swiss legal requirements.
We regularly monitor the Swiss health authorities (Swissmedic) website to stay informed about the latest pharmacovigilance updates.
Audits & Inspections
We provide support to your company during partner audits, regulatory inspections, and any other requests from Swissmedic.
ADR Reporting
We report adverse drug reactions (ADRs) to Swissmedic on your company’s behalf and forward any ADRs received from Swissmedic to your pharmacovigilance department.
We can carry out additional local activities such as case follow-up, assistance with case processing, and drafting of medical assessments.
Literature Monitoring
We monitor Swiss local journals not indexed in global databases to identify ADRs or other safety-relevant information related to your company’s products.
Safety Signals
We fully support your signal management activities, including the reporting of safety signals to Swissmedic.
Regulatory Reporting
We review and submit to Swissmedic your company’s periodic benefit-risk evaluation report (PBRER) and risk management plan (RMP).
Risk Minimization Measures
We review your local labelling safety updates.
We also support your company in implementing local additional risk minimization measures (aRMMs).
Other Services
We can assist you with a wide range of other activities and projects, including:
- Review of safety data exchange agreements (SDEAs) / pharmacovigilance agreements (PVAs)
- Training on various pharmacovigilance-related topics
- Interim staff coverage (maternity leave, workload peaks, …)
- And more…
About Us
Raemy Pharmacovigilance Services Sàrl is a consulting firm specializing in pharmacovigilance activities in Switzerland. Our main mission is to support pharmaceutical companies in achieving and maintaining compliance with Swiss pharmacovigilance regulations.
The firm was founded by Etienne Raemy, an experienced pharmacovigilance professional who has held roles of increasing responsibility across various organizations. Most recently, he served as Head of Pharmacovigilance at Debiopharm Research & Manufacturing SA, where he oversaw the pharmacovigilance system for marketed products and acted as the Swiss QPPV. Etienne holds a PhD in Biology from the University of Geneva.
Contact Us
Are you interested in working with us? Do you have any questions? Feel free to reach out!