The role of the QPPV is defined in EU regulations and the in the Good Vigilance Guidelines (GVP).
The person that takes on the role as EU QPPV also take on a great personal responsibility as the EU QPPV is responsible for all safety related activities globally for the marketing authorisation holder (MAH) towards EMA and the EU.
Often the EU QPPV role is provided by an external consultant working on behalf of Marketing Authorization Holder.
This contract template provide language adapted to a contract between an EU located contract QPPV and a US based Marketing Authorization Holder
Apart from general contract language the contract template also include Indemnification language for the QPPV which address the risk of potential litigation with an European Medicines Agency.
It is important that the any person that takes on that responsibility makes sure to have a clear indemnification from the MAH they work for to cover any legal costs related to the conduct of the QPPV role for the company.
The indemnification cover any situation where the QPPV has been acting in good faith and have been performing the duties as it would normally be expected in the profession. If there is clear misconduct on the QPPV side the QPPV must have a separate insurance covering such professional errors/mistakes.
It is also possible make a separate indemnification contract for instance if the EU QPPV is an employee of the MAH which can be found here
This is a draft template – Legal review is needed before finalizing any contract based on our templates