EU Qualified Person for Pharmacovigilance (EU QPPV)

Drug Safety & Pharmacovigilance Amsterdam, Netherlands


Description

Position Summary: 

As part of the pharmacovigilance system, the Marketing Authorisation Holder (MAH) – Seattle Genetics - has to have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance in the EU (QPPV) [DIR Art 104(3) (a)]. The EU QPPV has the authority over the pharmacovigilance system within Seattle Genetics which allows the QPPV to implement changes to the system and to provide input into risk management plans as well as into the preparation of regulatory action in response to emerging safety concerns.

The position reports into the SVP Risk Management and Pharmacovigilance.


Principal Responsibilities:

  • Establish and maintain the pharmacovigilance system
  • Provide oversight over the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, signal management compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance)
  • Act as a single pharmacovigilance contact point for the Competent Authorities in Member States and the Agency on a 24-hour basis
  • Ensure that any delegation by the QPPV of specific tasks to appropriately qualified and trained individuals is documented
  • Maintain awareness of the validation status of the global safety database, including any failures that occurred during validation and the corrective actions
  • Maintain awareness of significant changes to the database (e.g. those that could have an impact on pharmacovigilance activities)
  • Ensure that the pharmacovigilance system in place enables compliance with the requirements established for the production and submission of PSURs per[DIR Art 104(e)]
  • To influence the performance of the quality system and the pharmacovigilance activities, assisting in the transition to the PSMF (Pharmacovigilance System Master File)
  • Promote, maintain and improve compliance with the PV legal requirements within the EU
  • Maintain overview of medicinal product safety profiles and any emerging safety concerns via signal management process
  • Maintain an awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products
  • To be aware of and have sufficient authority over the content of risk management plan
  • To review and sign-off protocols for post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU
  • Inform relevant competent authorities in Member States immediately of any important safety concern identified in the course of a study
  • Ensure the conduct of pharmacovigilance and submission of all pharmacovigilance-related documents are in accordance with the legal requirements and GVP
  • Ensure quality, correctness and completeness of pharmacovigilance data submitted to the Competent Authorities in Members States and the Agency
  • Ensure a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
  • Provide any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency
  • Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals)
  • Act as a contact point for EU pharmacovigilance inspections and lead relevant inspections
  • Review compliance data on a periodic basis to ensure that commitments in the framework of risk management plans and post-authorisation safety systems are being adhered to
  • Review the schedule for pharmacovigilance audits and to trigger an audit where considered appropriate
  • Review the corrective and preventive action plan following each audit relevant to the pharmacovigilance system in order to assure that appropriate corrective actions are implemented
  • Maintain awareness of the sections of any contractual arrangements with third parties that relate to responsibilities for pharmacovigilance activities and safety data exchange in order to ensure that all necessary provisions relevant to the pharmacovigilance system are included and to request amendments where appropriate
  • Retain an establishment within the EU for the duration of the contract
  • Mange and develop PV staff in EU and collaborate with the cross functional teams
  • The MAH shall ensure that the QPPV has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the MAH [IR Art 10(2)]

 Qualifications:

  • Qualified Healthcare Professional with 5-10 years of experience in relevant fields; MD preferred
  • Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities [IR Art 10(1)]. Skills for the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences as well as epidemiology and biostatistics.
  • Where the QPPV has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC, the Seattle Genetics QPPV will be assisted by a medically trained person (i.e. in accordance with Article 24 of Directive 2005/36/EC)
  • The QPPV shall reside and operate in the EU [DIR Art 104 (3)]. Following European Economic Area (EEA) agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein.
  • Entrepreneurial, hands-on, with problem solving skills
  • Able to work independently and effectively in complex, rapidly changing environments
  • Sense of urgency
  • Flexibility, diplomacy, and the ability to manage expectations
  • Strong presentation/interaction and time management skills
  • Proven ability to establish strong partnerships with key internal and external stakeholders
  • thorough understanding of local compliance, as well as a sound ethical approach to business
  • Fluent in English, local language is a plus
  • A true passion for science and in making a difference in patient's lives
As a leading employer in our industry, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment.