Pharmacovigilance

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