Director Pharmacovigilance (QPPV) Europe / Amsterdam

Organisatie: GBT
Locatie: Amsterdam
Functie: Director Pharmacovigilance (QPPV) Europe
Vervaldatum: 10/02/2021
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This EU-based position (Paris, Amsterdam or Berlin) has the authority over the pharmacovigilance system within Global Blood Therapeutics (GBT) 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 actions in response to emerging safety concerns.

The position reports into the Vice President of Pharmacovigilance and Risk Management at GBT.

Essential Duties and Responsibilities:

  • Act as a single pharmacovigilance contact point for the Competent Authorities in Member States and the Agency on a 24-hour basis. The MAH shall ensure that the QPPV has enough authority to influence the performance of the quality system and the pharmacovigilance activities of the MAH [IR Art 10(2)]
  • Working with the GBT PV & RM team (in conjunction with the GBT vendor case processing and regulatory submission vendor) to establish and maintain the pharmacovigilance system including the pharmacovigilance system master file (PSMF)
  • Provide oversight of the PSMF including the quality system that consists of : standard operating procedures, contractual arrangements, case processing database operations, signal management ,compliance data regarding quality, completeness and timeliness of expedited ICSR; timeliness and quality of submission of periodic update reports (DSUR and PBRER); deviations, CAPAS, and audit reports; and assisting in developing appropriate training for key personnel involved in pharmacovigilance and risk management at GBT
  • Ensure that any delegation by the QPPV of specific tasks to appropriately qualified and trained such as a deputy QPPV is documented
  • Maintain awareness of the validation status of the global safety database, including any failures that occurred during validation and the corrective actions
  • Assess and communicate to GBT awareness of any significant changes to the safety database that could impact GBT’s ability to comply with all region-specific regulatory reporting requirements
  • Ensure that the pharmacovigilance system in place enables compliance with the requirements established for the production and submission of periodic reports including the PSUR per [DIR Art 104(e)]
  • Ensure GBT’s pharmacovigilance system (including the PSMF) is complaint with the PV legal requirements within the EU
  • Provide oversight 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 authorizations and other commitments relating to safety or the safe use of the products
  •  Review provide input and approval of content of risk management plans for products authorized in the EU
  • Review and sign-off protocols for post-authorization safety studies conducted in the EU or pursuant to a risk management plan agreed upon in the EU
  • Inform relevant competent authorities in Member States immediately of any important safety concern identified during 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 EMA (or Agency)
  • Ensure a full and prompt response to any request from the competent authorities in Members States and from the EMA (or 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 EMA (or 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-authorization 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
  • Qualifications:

  • Qualified Healthcare Professional (Master’s or PhD, MD preferred)
  • 7-10 years of experience in relevant fields
  • 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 GBT 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
  • Possess a sense of urgency and the ability to pivot in the ever-changing world of regional pharmacovigilance rules and regulations in the face of rapid global at GBT; and work independently across time zones
  • Possess keen time management skills, ability to present at the management and sometimes senior management level, as well as possess well- honed problem-solving skills
  • Ability to engage with key internal and external stakeholders in order to foster a continuous state of pharmacovigilance and inspection readiness
  • Be able to assess and communicate local compliance rules and regulations, as well possess an ethical approach to business
  • Fluent in English and applicable local languages
  • Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT’s Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity
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