Global Patient Safety BIS Lead (Director) Apply locations Boston, MA, USA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-3024
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. For the expansion of our Business Information Systems (BIS) team, argenx is looking for a Director level business partner to the Global Patient Safety (GPS). This role will report to the Global Commercial, Medical and GPS BIS Lead and will be the primary liaison to the GPS organization.
Roles and Responsibilities: Establish strong relationships with all levels of the Global Patient Safety (GPS) organization to deliver value-added solutions that meet the present and future needs of the organization. Collaborate with the GPS organization in developing and maintaining a patient safety centric roadmap of business capabilities, processes and technology solutions that is needed to support the strategy and mission of the GPS organization. Oversee implementation and operations of system integrators supporting argenx in this functional area. These include, but not limited to, safety case processing platforms, signal management and detection. Work closely with the Quality organization during new solution implementations and in operational management of systems to ensure compliance with quality and validation guidelines. This include, but not limited to, system documentation needed to be ready for Regulatory/Health Authority inspections. Implement and manage solutions for managing safety documentation that meet regulatory and quality guidelines. Provide technical guidance and oversight to vendors providing solutions to the GPS organization. As the system owner of PV systems, provide BIS support to internal and external audits and inspections. Work with GPS operations and global BIS teams in providing operational and analytical reporting solutions. Education, Experience and Qualifications: 10+ years of IT Industry work experience in Analysis, Design, Development, Testing and Maintenance of software applications in Health & Life Sciences with various types of Software Development Lifecycle methodologies. 5+ years of domain knowledge in Pharmacovigilance process and systems, Computer Systems Validation including FDA 21 CFR Part 11, GxP compliance and validation in a regulated environment. Solid grasp of Oracle Argus Safety system or another PV reporting platform like ArisGlobal LifeSphere MultiVigilance Platform. Experience in implementing Safety Signal Management and Detection systems like ORACLE Emprica. Minimum of 8-10 years working either in a biopharmaceutical company or a consulting organization with focus on the life sciences sector. Understanding of the industry landscape and global regulatory requirements (e.g. GxP, HIPAA, GDPR, etc.). #LI-Hybrid
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 ******. Only inquiries related to an accommodation request will receive a response.
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