[Remote] Regional Pharmacovigilance Senior Manager

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Note: The job is a remote job and is open to candidates in USA. argenx is a biotech company focused on transforming immunology and delivering innovative medicines for autoimmune patients. The Regional Pharmacovigilance Senior Manager will act as a scientific expert and resource for pharmacovigilance, ensuring compliance with regulatory requirements and enhancing processes within the region.Responsibilities• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Lead in the harmonization of processes across the regions• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Lead in the management of innovation projects for increasing Regional Team efficiency• Support the Regional PV Lead in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region• Support the Regional PV Lead in the revision of documents pertinent to Regional PV tasks• Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region• Contribute to the Pharmacovigilance System Master File (PSMF) data collection in the country/region• Contribute to increase the visibility of the GPS team/function throughout argenx with focus on the region• Closely collaborate with other functions including regulatory, marketing, medical, communications, quality, legal, as well as other teams as needed• Develop relationships with cross functional teams 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• Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team• 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 country/region• Drive Continuous Improvement initiatives as needed• May perform other tasks as appropriateSkills• At least 7-11 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 5 years in pharmacovigilance/drug safety• Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents• Knowledge of the drug development process, GXP quality and compliance requirements• Good presentation skills with the ability to communicate complex issues clearly• Good planning and organizational skills with ability to manage competing priorities• Good oral and written communication skills• Ability to motivate, influence, and collaborate with multidisciplinary teams• Ability to work independently and in a global environment• Understanding of safety business processes and systems for the collections of adverse events• Problem solving, conflict resolution and critical thinking skills• Relevant computer skills, including proficiency with Microsoft Office Suite• Fluency in written and spoken EnglishEducation Requirements• Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)Company Overview• argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. It was founded in 2008, and is headquartered in Boston, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website isCompany H1B Sponsorship• argenx has a track record of offering H1B sponsorships, with 4 in 2025, 5 in 2023, 4 in 2022, 3 in 2021. Please note that this does not guarantee sponsorship for this specific role.

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