Pharmacovigilance

At Meisys we are experts in all activities related with the detection, assessment, understanding and prevention of adverse effects, or any issue related to drug safety.

Drug safety is subject to very strict regulations, which makes this a vital service for any pharmaceutical laboratory. Many clients have already placed their trust in us to carry out pharmacovigilance work, whether for one-off consultancy services, audits or complete or partial auditing outsourcing, trusting us to represent them before the health authorities.

An important factor in pharmacovigilance is time. At Meisys we are committed to working around the client’s requirements to be able to meet the deadlines set both internally and by the health authorities.

Some of our services are:

Drafting Standard Operating Procedures (SOP).

Pharmacovigilance training for employees.

Risk Management Plans.

Pharmacovigilance System Master File (PSMF).

On site and temporary technical support.

Periodic Safety Update Reports (PSURs).

Literature searches to detect adverse effects.

24-hour telephone support.

Comprehensive service in pharmacovigilance.

We act as local PV “pharmacovigilance contact person” specialists (QPPVs) for laboratories that don’t have a headquarters based in Spain.

 MEISYSFV

At Meisys we have developed our own exclusive application for managing drug safety information, based on the ICH of electronic transmission defined by the EMA (European Medicines Agency). Some of its features include:

Web access or implementation in local servers.

Creation of CIOMS and CIOMS-II reports.

Exporting to XML format.

Importing from XML format. Total application integration.

Easy searching with multiple filters.

Creating alerts via defined searches.

Tool customisation according to client requirements.