Pharmacovigilance services

Scientific literature screening support

We will manage global and local scientific literature search to establish the most significant source of information in monitoring the safety profile and the risk-benefit balance of medicinal products. This is particularly relevant in relation to detecting new or emerging safety signals or issues.

Literature search for safety data

When you have submitted an MA (marketing authorisation) application, it is a regulatory requirement for you as the marketing authorisation holder of a medicinal product to perform regular searches of the scientific literature.

This is an important source of patient safety data which might contribute to the safety profile of your medicinal product.

Why use our support with scientific literature screening?

Arex Advisor experts will:

-Set up, review and approve search criteria in the global literature database (PubMed or EMBASE).
-Select and review relevant scientific journals in the framework of local literature screening.

More Pharmacovigilance services

Adverse event management and case reporting
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.