Pharmacovigilance support

Adverse event management and case reporting

Adverse events must be carefully monitored and reported in a timely manner. Our support will ensure safety, as well as appropriate care and medical support for patients experiencing undesirable signs and symptoms during treatment.

Reporting for mandatory compliance

Reporting of adverse events to regulatory authorities is mandatory. It requires monitoring and documenting adverse event reports according to global and national requirements. This is applicable to both clinical trials and marketed medicinal products.

Why use our support with adverse event management and case reporting?

Arex Advisor experts will:

– Manage adverse events in a timely manner in accordance with the applicable legislation
– Detect patient safety issues
– Mitigate relevant safety risks for clinical trials and postmarketing use of the medicinal product

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.