Establishing and maintaining the PV system in the EU. Promoting, maintaining, and improving compliance with the European legal requirements.
Review and approval of protocols of any Post-Authorisation Safety Studies (PASS) conducted in the EU or pursuant to a RMP agreed in the EU, as well as maintaining awareness of any PASS requested by a Competent Authority (CA), including the results of such studies.
Maintaining awareness of risk minimisation measures for the medicinal product covered by the PSMF and having sufficient authority over the content of Risk Management Plan (RMP).
Oversee the safety profiles and any emerging safety concerns regarding the medicinal product(s) as covered by the PSMF. As well as maintaining awareness of any conditions or obligations adopted as part of the marketing authorisation and other commitments relating to the safety or the safe use of the product.
Ensure conduct of pharmacovigilance and submission of all PV related documents in accordance with the legal requirements and Good Pharmacovigilance Practices (GVP), including the correctness and completeness of pharmacovigilance data submitted to the competent authorities and to the European Medicines Agency (EMA).
Act as a single pharmacovigilance contact point for the CAs, EMA and inspection on a 24/7. Ensuring a full and prompt response to requests from the CAs in Member States and from the EMA for the provision of information related to the safety and risk management of the medicinal product(s). And providing input into the preparation of regulatory action in the EU in response to emerging safety concerns.
In certain member states within the EU, there is a requirement for the nomination of a pharmacovigilance person at
QVigilance can not only offer support in understanding which EU countries require a local representative but can also provide a network of local representatives in these individual countries to meet any specific local pharmacovigilance requirements