Pharmacovigilance

Pharma Services Switzerland

Swiss laws and regulations on drug safety must be complied with so that risks can be detected and minimized. To ensure this, we offer the following services:

Establishment of a PV quality management system (QMS), including a local Pharmacovigilance System Master File (PSMF) and pharmacovigilance standard operating procedures (SOPs)
Preparation and execution of pharmacovigilance audits
Taking over the function of the local responsible person for pharmacovigilance
Recording and handling of adverse reaction reports and other PV issues as well as follow-ups, incl. internal forwarding and reporting to Swissmedic
Submission of RMPs, PSURs and signal reports to Swissmedic
Creation and dispatch of Direct Healthcare Professional Communications (DHPCs) and additional Risk Minimizing Measures (aRMMs)
Product-related search of current, local literature and foreign health authority websites.
Responding to product-related medical inquiries
Consultation and training