[Remote] Regional Pharmacovigilance Senior Manager

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 https://www.argenx.com/.

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.

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