Global Pharmacovigilance Lead
hace 17 horas
About Argenx
Argenx is a biotechnology company dedicated to discovering and developing innovative treatments for patients with severe autoimmune diseases.
Job Summary
We are seeking an experienced Global Pharmacovigilance Lead - Regulatory Expert to join our team. This role will be responsible for ensuring adherence to local/regional safety regulatory requirements and enhancing processes as needed while maintaining consistency with global standards.
Key Responsibilities
This position will serve as the point of contact for pharmacovigilance in assigned countries/regions, establishing and maintaining pharmacovigilance systems specific to these areas. The successful candidate will promote awareness and compliance with pharmacovigilance obligations, provide support for responses to local regulatory requests, and communicate global procedures and practices.
Requirements
To succeed in this role, you will need advanced knowledge of pharmacovigilance regulatory requirements globally, including GVP guidance documents. Robust knowledge of the drug development process, GXP quality, and compliance requirements is also essential. A Master's degree in pharmacy, nursing, healthcare, or a related field, along with at least 7 years of experience in the pharmaceutical/biotech industry and 5 years in pharmacovigilance/drug safety, is required.
Estimated Salary: $140,000 - $170,000 per year
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