Pharmacovigilance Services

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.

Extensive experience of human and veterinary medicines, medical devices, general products, herbal medicines, borderline products, food supplements and cosmetics.

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