EU Global Regional Lead

hace 1 día

Murcia, España Argenx A tiempo completo

PURPOSE OF THE FUNCTION

  • Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region.
  • Assess current processes to ensure adherence to local/regional safety regulatory requirements and - where needed - enhance and/or develop new processes while assuring consistency with global standards.

ROLES AND RESPONSIBILITIES

  • Act as point of contact for pharmacovigilance in the assigned countries/region.
  • Establish and maintain the applicable pharmacovigilance system specific to the countries/region.
  • Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the countries/region.
  • Provide support to responses to local pharmacovigilance related regulatory requests.
  • Communicate global procedures and practices and monitor implementation.
  • Lead the preparation of Pharmacovigilance Agreements (PVA) in collaboration with other departments.
  • Engage in due diligence activities as needed in the region when potential business partnerships or collaborations may take place.
  • Increase the visibility of the GPS team/function throughout argenx with focus on region.
  • Participate in health authority interactions throughout the product life-cycle as needed. Closely collaborate with other functions including regulatory, medical, communications, quality, legal, as well as other teams as needed.
  • Progress understanding and education of safety requirements for pharmacovigilance and other relevant regulations cross-functionally to ensure patient safety and compliance with local and global requirements.
  • Develop relationships with cross functional teams and with business partners as it relates to adverse event reporting and other pharmacovigilance activities.
  • Maintain an in depth knowledge of local regulations, expectations and regulatory authority contacts and perform activities related to the interpretation and review of existing and evolving safety requirements.
  • Lead and actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the global Quality team.
  • Contribute to GPS issue management, recommend and implement action plans for mitigation.
  • Identify opportunities to align PV standards globally.
  • Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.
  • Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance in the region.
  • Transparently communicate and/or escalate issues to GPS leadership as appropriate.
  • Drive Continuous Improvement initiatives as needed.
  • May perform other tasks as assigned by line manager or Head of GPS.

SKILLS AND COMPETENCIES

  • Excellent presentation skills with the ability to communicate complex issues clearly.
  • Relevant computer skills, including proficiency with Microsoft Office Suite including PowerPoint / Visio.
  • Excellent planning and organizational skills with ability to manage competing priorities.
  • Excellent oral and written communication skills - fluency in written and spoken English required.
  • Strong ability to motivate, influence, and collaborate with multidisciplinary teams.
  • Ability to work independently and in a global environment.
  • Solid understanding of safety business processes and systems for the collection and evaluation of adverse events.
  • Problem solving, conflict resolution and critical thinking skills.
  • Demonstrated ability to author or contribute to complex documents.
  • Line Management experience is not required, but experience in the oversight of functional teams would be a plus.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

  • Master’s degree (or country equivalent) in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus).
  • At least 7 or more years of experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (experience with adverse event monitoring and reporting with digital/social media, market research, and relevant commercial and marketing related projects and programs is a plus).
  • Advanced knowledge of pharmacovigilance regulatory requirements globally including and GVP guidance documents.
  • Robust knowledge of the drug development process, GXP quality and compliance requirements.
  • Equivalent and adequate combination of education and experience.
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