Pharmacovigilance Services

Callisto Consulting can support you in:

• Setting up quality systems to fulfil Marketing Authorisation Holders Pharmacovigilance obligations.
• Weekly literature searching to identify potential adverse events related to Marketing Authorisation Holders products.
• Collation, assessment, follow-up and reporting of spontaneous adverse reactions received by the Marketing Authorisation Holder.
• Electronic reporting via EVWeb.
• Review of PVORs.
• Preparation of Periodic Safety Update Reports.
• Signal detection Safety Reports.
• Maintenance of product information including SmPC, leaflet and labelling.
• Appropriate Qualified Person and Deputy Qualified Person for Pharmacovigilance including 24-hour cover.
• Provision of Medically Qualified Person.
• Provision of 24 hour medical information services.
• Production of Risk Management Plans and implementation of Risk Minimisation Measures.
• Provision of Pharmacovigilance training.
• Auditing existing Pharmacovigilance systems.
• Preparation for and assistance during Pharmacovigilance inspections.