Elara Pharmaservices Europe with the support of our sister company Callisto Consulting can assist 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 activities including preparation of Safety Reports.
- Maintenance of product information including SmPC, leaflet and labelling.
- Appropriately Qualified Person and Deputy Qualified Person for Pharmacovigilance including 24-hour cover.
- 24 hour provision of Medically Qualified Person.
- 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.