Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
argenx is looking for a Regional Pharmacovigilance Lead to serve as a scientific expert and pharmacovigilance resource to external and internal partners within the region. This individual will assess current processes to ensure adherence to local/regional safety regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with global standards.
Roles and Responsibilities:
Act as point of contact for pharmacovigilance in the assigned countries/region
Establish and maintain the applicable pharmacovigilance system specific to the countries/region
Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the countries/region
Provide support to responses to local pharmacovigilance related regulatory requests
Communicate global procedures and practices and monitor implementation
Lead the preparation of Pharmacovigilance Agreements (PVA) in collaboration with other departments
Engage in due diligence activities as needed in the region when potential business partnerships or collaborations may take place
Increase the visibility of the GPS team/function throughout argenx with focus on region
Participate in health authority interactions throughout the product life cycle as needed
Closely collaborate with other functions including regulatory, medical, communications, quality, legal, as well as other teams as needed
Progress understanding and education of safety requirements for pharmacovigilance and other relevant regulations cross-functionally to ensure patient safety and compliance with local and global requirements
Develop relationships with cross functional teams and with business partners 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
Lead and actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the global Quality team
Contribute to GPS issue management, recommend and implement action plans for mitigation
Identify opportunities to align PV standards globally
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 region
Transparently communicate and/or escalate issues to GPS leadership as appropriate
Drive Continuous Improvement initiatives as needed
May perform other tasks as appropriate
Skills and Competencies:
Excellent presentation skills with the ability to communicate complex issues clearly
Excellent planning and organizational skills with ability to manage competing priorities
Excellent oral and written communication skills
Strong 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
Demonstrated ability to author or contribute to complex documents
Relevant computer skills, including proficiency with Microsoft Office Suite
Fluency in written and spoken English
Education, Experience and Qualifications:
Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
At least 5-8 years of experience in the pharmaceutical/biotech industry with at least 3 years in pharmacovigilance/drug safety (experience with adverse event monitoring and reporting with digital/social media, market research, and relevant commercial and marketing related projects and programs is a plus)
Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
Knowledge of the drug development process, GXP quality and compliance requirements
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At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.