Instead of creating a dedicated in-house service, Vigipharm will manage all aspects of your health vigilance department. Depending on the fields of activity, this service includes:
• Managing incoming calls. Telephone calls from health-care professionals and patients are re-routed to Vigipharm.
• Recording of Adverse Events (AE). We ensure receipt of notifications, documentation, medical analysis, MedDRA coding, as well as declaration of notifications, in accordance with the deadlines and regulatory requirements.
• Providing medical expertise. We assess causality of adverse events (AE) and the product using two methods (French and WHO).
• Assuming the role of European or local Qualified Person Responsible for Pharmacovigilance. We propose experts who can represent you with the authorities.
• Managing your database. We enter data for pharmacovigilance cases and keep your database updated.