Ergomed
Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (home
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The EU QPPV is responsible for:• The establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the Company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community; • Ensuring that any request from the CAs for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a medicinal product is answered fully and promptly; • Provision to the CAs, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on planned post-authorisation safety studies.