What are the responsibilities and job description for the Senior Director, Safety Data and Systems position at Argenx?
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.
Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.
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.
The Senior Director, Safety Data and Systems will oversee and coordinate deliverables related to GPS Safety Signal Management and Safety Risk Management. Additionally, this role will be responsible for leading and managing the execution of GPS Safety Data Management and System Maintenance initiatives, driving continuous improvement and operational excellence.
Reporting to the Head of Global Patient Safety Operations, the Senior Director, Safety Data and Systems will facilitate cross-functional collaboration across GPS and key departments, including Business Information Systems (BIS), Quality, and Regulatory Affairs, to ensure seamless coordination and optimal outcomes. He / she will also lead strategic development and implementation of innovative solutions designed to drive efficiency and the highest quality standards.
Roles and Responsibilities :
- Collaborate with applicable GPS functional areas to evaluate opportunities for technology-based process improvements.
- Partner with the Quality functions to ensure compliance with all applicable quality and validation standards.
- Represent GPS Safety Systems in interactions with applicable argenx functions (e.g. Quality, Regulatory, Data Management, Business Information Systems, Quantitative Science) regarding pharmacovigilance technical roadmap, setup, and operation.
- Provide expert technical and operational guidance to safety vendors and internal staff.
- Support GPS business owners of pharmacovigilance systems and assume the business owner role when designated, driving continuous system enhancement and operational support.
- Oversee and guide GPS collaboration with Safety vendor on safety database upgrades and major Safety database configuration changes.
- Direct the development and maintenance of safety database queries, safety analysis, and tracking tools.
- Lead the development and implementation of procedural documents such as SOPs, Work Instructions, job aides, and other documents and conventions as applicable.
- Maintain advanced expertise on applicable regulatory and PV tech guidelines and share with GPS team members as applicable.
- Get involved in additional tasks and projects as assigned by the line manager or Head of GPS.
Skills and Competencies :
Education, Experience and Qualifications :
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.
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