TMC can provide a comprehensive suite of pharmacovigilance services
TMC's medical and pharmacovigilance professionals work together to provide a comprehensive suite of pre- and post-marketing pharmacovigilance services.
MedicalPharmacovigilance
Pre-approval services
• Provision of Responsible Person for Pharmacovigilance (RP) for clinical trials
• EudraVigilance registration
• Medical review and assessment of serious adverse events
• SUSAR reporting to EudraVigilance and Competent Authorities
• Ongoing medical safety surveillance and risk/benefit assessment
• Annual Safety Reports (ASRs)
Post-approval services
• Provision of Qualified Person for Pharmacovigilance (QP) for marketed products
• EudraVigilance registration
• Literature surveillance
• SUSAR reporting to EudraVigilance and CAs
• Periodic safety update reports (PSURs)