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The QPPV shall be responsible for the establishment and maintenance of the marketing authorization holder’s pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities [and to promote, maintain and improve compliance with the legal requirements.
**ACCOUNTABILITIES**
Role and responsibilities of the QPPV as outlined in EMA Guideline on goodpharmacovigilance practices (GVP) Module I - Pharmacovigilance systems and their quality systems.
- Act as the EU QPPV per EU legislation requirements and as such, works to ensure compliant implementation of all relevant regulatory requirements
- Act as a single pharmacovigilance contact point for the EEA competent authorities for all EEA Member States and the European Medicines Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections. With Quality Assurance, prepare for and participate in Health Authority Inspections and internal audits as applicable. Ensure an appropriate backup process for the EU QPPV role is in place and is regularly tested.
- Supervise the management of the EU Pharmacovigilance System Master File (PSMF)
- Implement and oversee any/all global safety system issues impacting EU regulations and responsibilities, including the participation in the review, update and implementation of GPSE policies and procedures impacting EU regulations and the responsibilities of the EU QPPV.
- Provide input to and interpretation of pharmacovigilance legislation and guidance in the EU as appropriate. Ensure the communication of new EU legislation and guidance and ensures that any impact on Takeda pharmacovigilance processes is addressed.
- Interface with the Local Operating Countries (LOC) management functions to achieve oversight of EEA LOC PV activities for all products with a market authorisation in the EEA.
- Oversee all medicinal product safety profiles, for products with or pending market authorisation in the EEA, including any emerging safety concerns including awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of these products, including risk minimisation measures.
- Lead Takeda’s commitment and efforts to promptly identify emerging potential and/or urgent safety issues, to ensure the management of the safety risk identified, and to communicate accordingly and is accountable for the escalation of any new potential safety issues to the Head of GPSE as applicable.
- Ensure a full and prompt response to any request from the EEA competent authorities in Member States and the European Medicines Agency as necessary for support of a benefit-risk evaluation of a medicinal product, and to provide any additional information relevant to the benefit-risk evaluation when applicable.
- Have oversight of all Risk Management Plans (RMPs) for products with or pending market authorisation in the EEA and the ability to influence content of these RMPs and associated risk minimisation measures.
- Accountable for the implementation of medical and scientific expertise to ensure appropriate measures for risk assessment and prevention/minimization for all applicable marketed products, including all marketed products in the EEA (directly or through formal delegation), including the oversight of signal detection and risk management activities for these products
- Review and approval of protocols of post-authorisation safety studies conducted in the EEA or those associated with an EU approved RMP.
- Have oversight of post-authorisation safety studies requested by an EEA competent authority including the results of such studies.
- Provide input into the preparation of regulatory action in response to emerging safety concerns for medicinal products with a marketing authorisation in the EEA (including safety variations, urgent safety restrictions, and communication to patients and healthcare professionals). Work closely with Head of PV Affiliate Relations (PVAR), GPSE and with the EU and Europe Drug Safety Officers (DSOs)/Patient Safety Leads in the countries, and those performing local pharmacovigilance including the local and regional PV Qualified Persons.
- Partner with all functions at Takeda including but not limited to Global Compliance and Standards, Global Regulatory Affairs, the Local Operating Countries (LOC) management function and Quality Assurance to ensure the company meets its legal obligation pertaining to EU regulation for the monitoring of the products with a marketing authorisation in the EEA:
- Including the monitoring of performance/compliance, training, the conduct of pharmacovigilance and submission of all pharmacovigilance related documents in accordance with the legal requirements and EU GVP.
- Including ensuring the necessary quality, accuracy and inclusivity of pharmacovigilance data submitted to the competent authorities in Europe, the
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