Regional Pharmacovigilance Lead Manager

7 days ago


Boston, Massachusetts, United States Lifelancer Full time
About the Role

We are seeking an experienced Regional Pharmacovigilance Lead to join our team at argenx. This is a critical role that will involve serving as a scientific expert and pharmacovigilance resource to external and internal partners within the region.

The ideal candidate will have a strong understanding of safety business processes and systems for the collection of adverse events, as well as excellent planning and organizational skills with the ability to manage competing priorities.

This role offers a competitive salary of $120,000 - $150,000 per annum, depending on experience, plus a range of benefits including health insurance, retirement savings plan, and paid time off.

In this role, you will be responsible for assessing current processes to ensure adherence to local/regional safety regulatory requirements and enhancing or developing new processes where needed, while assuring consistency with global standards.

You will also act as a 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, and provide support to responses to local pharmacovigilance related regulatory requests.

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


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