• Job Description

  Req#: R0092619

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  Job Description

  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.

  • Is a member of the Takeda Safety Board (TSB) for the review of products that are marketed or undergoing licensing submission application in the European Union/European Economic Area (EU/EEA) countries.

  • 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:

  o 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.
  o Including ensuring the necessary quality, accuracy and inclusivity of pharmacovigilance data submitted to the competent authorities in Europe, the EEA and the European Medicines Agency (EMA).

  • Work closely with the Head of GPSE, each GPSE functions and stakeholders, to ensure that performance and maintenance of the pharmacovigilance system is fully compliant. This includes partnering on pharmacovigilance processes including Individual Case Safety Reports (ICSR) collection and reporting, PSMF maintenance, production of PSURs (and other such documents), production and execution of Risk Management Plans and Signal Management, and other applicable processes to ensure adequate monitoring and escalation of compliance in relation to the pharmacovigilance system in accordance with the legal requirements and EU GVP.

  • Participate in the collection, evaluation and communication (externally to authorities, health professionals and patients; internally to upper management, clinical research, regulatory affairs, medical information, etc.) of post-marketing safety data from all sources regarding Takeda’s globally marketed products in order to ensure patient safety

  • Provide expertise on EU GVP legislation to support both internal and external partners, including requisite internal and external audits.

  • Be engaged in the review and oversee as required Takeda’s Pharmacovigilance systems, incl. quality control, quality assurance, database, SOPs, compliance, audits, training

  • Collaborate with the Head of GPSE Compliance ensuring the oversight and coordination of PV activities across Takeda and in overseeing vendor related activities, in relation to compliance and quality measures. Engaged in the oversight of vendor activities associated with above products, as these will include those products with a marketing authorisation in the EEA

  • Collaborate with relevant QA functions to ensure timely audit and inspection responses for the GPSE function and assignment of appropriate ownership of corrective and preventative action plans (CAPAs) by PV subject matter experts (SMEs) for EU/EEA territories.

  • Proactively work to modify compliance processes in real-time with changing regulations.

  • Where specific tasks are delegated, as EU QPPV, will maintain oversight and ensure adequate documentation of such delegations.

  • Participate in and oversee talent management strategies such as annual reviews, performance management, succession planning and employee development and retention.

  • Support and advocate the vision and mission of GPSE and contribute to creating and communicating an employment culture and values which attract, retain and develop the most effective people at all levels. Ensure compliance with external regulatory, medical/scientific standards and assisting in optimizing development projects in line with Takeda’s strategy and budget.

  EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • Medical degree preferred, and/or other professional Doctorate degree in Pharmacy or Sciences

  • Previous experience as an EU QPPV, or deputy desired but not essential

  • Prior experience with regulatory inspections with a focus on Pharmacovigilance

  • Demonstrated strong leadership and managerial capability, with developed skills in team building, motivating and developing people and managing with a matrix environment

  • Experience of operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.

  • Excellent communication and influential skills with strong written and presentation skills.

  • Demonstrated in depth knowledge of regulatory agency requirements and expectations, particularly in the EU, regarding drug safety and an understanding of general drug safety methodologies.

  • Excellent organisational skills and ability to prioritise and delegate activities with the ability to successfully manage multiple critical issues simultaneously

  Locations

  Brussels, Belgium

  Worker Type

  Employee

  Worker Sub-Type

  Regular

  Time Type

  Full time

• About the company

  Hope and empathy. These two words are not often associated with pharmaceutical companies. But here at Takeda, our people are motivated to serve patients with integrity, respect, and empathy. Driven by our mission, we seek to bring hope of better health and a brighter future to those we impact. To do this, we focus on our chosen core therapeutic areas: Oncology Gastroenterology Neuroscience Develop life-saving vaccines No matter the region, business unit, function, or team, everyone at Takeda matters. Every one of our employees is a vital contributor to our bold, inspiring mission.

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