Svp, Head of Global Patient Safety - Boulogne-Billancourt, France - IPSEN

IPSEN
IPSEN
Entreprise vérifiée
Boulogne-Billancourt, France

il y a 1 semaine

Sophie Dupont

Posté par:

Sophie Dupont

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Description

Title:

SVP, Head of Global Patient Safety


Company:

Ipsen Pharma (SAS)

  • The Senior Vice President, Global Patient Safety is accountable to define the overall Patient Safety strategy for Ipsen across the portfolio (Oncology, Neurosciences, Rare Diseases) from Discovery to development and post marketing approvals' maintenance, in order to meet international regulatory requirements as well as Ipsen regulatory and development objectives and Patient safety. The SVP, Global Patient Safety is accountable to maintain uptodate safety risk profile of Ipsen's products and to implement meaningful risk minimization actions with the ultimate goal "being the guardian of patient's safety".
  • Be an active member of the CMO leadership team and the Ipsen Global Leadership team

Main responsibilities / job expectations

Ensure the provision of high quality systems and data for the accurate monitoring of the safety:

  • Ensure the quality & integrity of the company's safety database resulting from the administration of all company compounds/assets during the entire product's life cycle from development till registration withdrawal.
  • Ensure Ipsen's pharmacovigilance quality management system compliance with applicable PV worldwide regulations by having all PV procedures documented in Policy, Standard Operating Procedures (SOP), forms and specifications and by assuring that such quality documents are understood, regularly reviewed and reflect stateoftheart.
  • Ensure the existence and operation of a high quality and cost effective support systems for pharmacovigilance (information databases, signal detection systems etc).
  • Guarantee accuracy, completeness and quality of safety data collected and reported
  • Ensure in cooperation with the Ipsen EU QPPV, Global Quality and Global R&D Quality functions the conduct of internal and external audits based on an approved annual plan established thanks to the Ipsen global quality risk assessment tool.

Be responsible for up-to-date safety risk profile and risk minimization for each Ipsen's product

  • Ensure appropriate process for potential risk definition, monitoring and evaluation through translation safety activities in collaboration with nonclinical safety and through draft risk management plans
  • Ensure robust signal management end to end process including the execution of risk minimization measures
  • Coown with R&D/Medical affairs the benefitrisk balance of all Ipsen's products and contribute to the evaluation of the risk benefit of each compound and to inform the clinical development teams and medical science teams of any changes to risk benefit profiles
  • In the case of identification of new safety information initiate immediate fact finding to confirm the extent of the problem & the precise contributory role of the test or marketed product.
Upon consultation with senior management & medical experts initiate the necessary action:
information of regulatory agencies, activation of the crisis management cell for product recall.


Ensure the approval and submission of accurate, high quality pharmacovigilance reports and documentation within international regulatory timelines:

  • Timely produce to internal and external customers of validated pharmacovigilance reports or other safety reviews for incorporation into development or regulatory documentation both during development and after marketing authorisation approval, to meet international regulatory guidelines which are acceptable to regulatory authorities such that there is no delay in the granting or maintaining of marketing authorisations.
  • Contribute to the development and submission of filing dossier by being responsible of any safety documents.

Represent Global Patient Safety with external partners / authorities:

  • Represent Global Patient Safety in meetings and inspections with Regulatory Agencies when needed
  • Represent Global Patient Safety with external business partners when needed
  • Represent Global Patient Safety in congresses and key meetings with KOL
  • Is a key stakeholder during Due Diligence processes to ensure the assessment of the safety profile of potential new asset.

Collaborate with internal stakeholders to create a Patient Safety culture:

  • Promote the Ipsen Patient Safety Strategy across the Ipsen organization contributing to the Ipsen Strategy
  • Work crossfunctionally with all Ipsen's functions and provide necessary pharmacovigilance data and/or reports in instances of crisis / product recall etc.
  • Be available at all time to provide senior management with up to date assessments on product safety
  • Develop, plan and implement Patient Safety training courses for Ipsen staff
  • Global and local Patient Safety team as well as all other staff office or field based.
  • Ensure robust oversight and control of PV service providers through a rigorous assessment process and monitoring plan of PV services delivered.
**Create a high performing team to exec
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