Pharmacovigilance Unit

The development and management of a pharmacovigilance system is a procedure required in the context of every clinical trial to ensure the patient’s/participant’s safety. Therefore, it is very important to have the necessary resources and optimized processes, as well as an effective planning to ensure the appropriate completion and management of the  activities required in pharmacovigilance.

It is necessary to have knowledge of the European and international legislation that allows to develop these activities beyond national borders (Reporting to EudraVigilance) to have ongoing studies in which safety information is managed in different countries.

Experior has a highly qualified professional team with this  training and large experience that provides the service required for the interpretation, coding and reporting  of any serious adverse event or relevant safety information, ensuring a management adapted to the project based on the current legislation and the established deadlines.

Pharmacovigilance unit expressed in figures

Active studies with global sites distribution

SAEs managed

SUSARs reported

DSURs (development safety update report) drafted and reported.

Services and methodology being offered

The pharmacovigilance professional team of Experior has the ability to offer to their clients a number of services, during the clinical research phase and the post-marketing phase:

  • Collection and coding according to MedDRA (Medical Dictionary for Regulatory Activities), record, evaluation and follow-up of the Serious Adverse Events (SAEs).
  • Expedited reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to the competent authorities within the deadline required by the legislation, nationally and internationally (EudraVigilance).
  • Validation, use and maintenance of an internal pharmacovigilance database in which all the events received and managed are recorded and where activities to be performed can be planned.
  • Drafting, approval and reporting  of  Development Safety Update Reports (DSURs) based on ICH guideline E2F to the Authorities.
  • Periodical reconciliations of adverse events recorded in the eCRF vs pharmacovigilance database.
  • Being  a liaison in terms of safety for competent authorities and the study team (CRAs) as well as to provide training related to safety management and to review the safety section of  protocols.
  • Pharmacovigilance training for investigators and staff involved in the trials .

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