Job Description
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 appropriate Skills • 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 English Education 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 is Company 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. Apply tot his job