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