Global Pharmacovigilance Lead

hace 4 semanas


Murcia, Murcia, España Argenx A tiempo completo
Job Summary

We are seeking a highly skilled and experienced Pharmacovigilance Lead to join our team at Argenx. As a key member of our Global Pharmacovigilance team, you will be responsible for ensuring the safe and effective use of our products in the region.

Key Responsibilities
  • Act as a 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 enhance and/or develop new processes as needed.
  • 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.
  • Participate in health authority interactions throughout the product life-cycle as needed.
Requirements
  • Master's degree (or country equivalent) in pharmacy, nursing, healthcare or other life-science or technical field.
  • At least 7 or more years of experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety.
  • Advanced knowledge of pharmacovigilance regulatory requirements globally including and GVP guidance documents.
  • Robust knowledge of the drug development process, GXP quality and compliance requirements.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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