Pharmacovigilance

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.

 

EU pharmacovigilance contact requirements

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.

Why use our support with local PV functions and medical information?

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

More pharmacovigilance services

Adverse event management and case reporting
Scientific literature screening
Maintenance support of PV system, including writing of SOPs and PSMF
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.