Pharmacovigilance

To ensure compliance with the Swiss laws and requirements:

• Establishment of local Pharmacovigilance System Master Files (PSMFs) and pharmacovigilance SOPs
• Preparation and execution of pharmacovigilance audits
• Taking over the function of the local responsible person for pharmacovigilance
• Recording of adverse reaction reports and follow-up 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
• Pharmacovigilance training