As your trusted partner, we ensure that your pharmacovigilance system is compliant with regulatory requirements. Arex Advisor Experts are qualified and trained to take on the role of QPPV and/or dQPPV.
The Qualified Person for Pharmacovigilance (QPPV) is a legally mandated role t for all pharmaceutical companies seeking to authorise medicinal products in the EU/EEA, Switzerland and the UK. The QPPV holds ultimate responsibility for ensuring compliance with pharmacovigilance requirements and acts as the primary contact person for authorities during inspections.
This role requires 24/7 availability to respond to authority inquiries and ensure the continuous oversight of product safety.
Arex will work together with the client to ensure that the pharmacovigilance system is fully functional, by:
With our expertise, you can focus on your core business while we safeguard your compliance and product safety.
Adverse event management and case reporting
Scientific literature screening
Effective PV systems for the Nordics
Local PV function, including medical information
Lovisa Rosenquist
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.
