argenx · 14 hours ago
Regional Pharmacovigilance Senior Manager
United States
Full-time
Remote
Senior Level
7+ years expargenx is a biotech company focused on transforming immunology and delivering medicines for autoimmune patients. The Regional Pharmacovigilance Senior Manager will serve as a scientific expert and resource for pharmacovigilance, ensuring adherence to regulatory requirements and enhancing processes within the region.
BiotechnologyClinical TrialsTherapeutics
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
Qualification
Required
Master's degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
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
Benefits
Short-term and long-term incentive programs
Retirement savings plans
Health benefits
Company
argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.
1001-5000 employees
H1B Sponsorship
argenx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2023 (5)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$3.75BKey Investors
OrbiMed,Seventure PartnersForbion Capital Partners
2023-07-18Post Ipo Equity· $1.1B
2022-03-23Post Ipo Equity· $700M
2021-02-02Post Ipo Equity· $999.38M
Leadership Team
Karen Massey
Chief Operating Officer
Carine Rivet-Thions
Associate Director Regulatory Affairs Labeling
Recent News
2026-02-02
belganewsagency.eu
2026-01-16
2026-01-16
Company data provided by crunchbase