Pharmacovigilance support
Local PV function & medical information
With our support you will get a local service solution and country-level pharmacovigilance operations where it is required by the national legislation.
With our support you will get a local service solution and country-level pharmacovigilance operations where it is required by the national legislation.
Some national competent authorities within the EU request the nomination of a contact person for pharmacovigilance issues at a national level. They should speak the local language, reside within the given Member State and have a direct reporting link to the EU-QPPV.
Arex Advisor experts have competence to:
-Communicate with the national competent authorities and stakeholders requesting medical information in the local language.
-Monitor locally published scientific literature.
-Local processing of safety data and reporting to the local competent authority.
-Monitor the national regulatory intelligence.
-Local support in Risk Management Plans, Periodic Safety Update Reports and Development Safety Update Report handling and submission.
-Our languages are: English, Swedish, Danish, Norwegian, Finnish, German, French, Dutch, Russian
Adverse event management and case reporting
Scientific literature screening
Effective PV systems for the Nordics
PV training services
Lovisa Rosenquist
Arex Advisor AB
Arex Advisor AG
Contact us
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.