Pharmacovigilance support

Global safety database services

We will enter and carefully analyse adverse events in the safety database, which will be the main repository for collected safety data. Moreover, we will report individual cases and aggregate safety information to the relevant authorities within required timelines using GateWay solution integrated in the safety database.

About the global safety database

A safety database is used to track and manage safety reports from clinical trials and the use of marketed medicinal products.

Why use our support with global safety database services?

Arex Advisor experts will:

  • set up and validate the safety database in compliance with regulatory requirements and business purposes
  • use the safety database to its full potential, due to having end-user training and experience

More Pharmacovigilance services

Scientific literature screening
Maintenance support of PV system, including writing of SOPs and PSMF
Local PV function, including medical information
PV training services

Your contact person

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.