Safety Operations Manager, Global Patient Safety

The Safety Operations Manager, Global Patient Safety, will lead the operational aspects of the Global Patient Safety (GPS) team at argenx, a biotech company focused on developing medicines for autoimmune diseases. Argenx is known for its innovative approach, particularly with VYVGART, a treatment for generalized myasthenia gravis (gMG) and other severe autoimmune conditions. The company aims to expand its reach and impact through a diverse pipeline of assets. The manager's daily tasks include overseeing the coordination and communication between safety vendors, GPS teams, and other internal and external parties. This involves managing case triage, processing, and reporting, as well as ensuring compliance with regulatory requirements. The role also includes supporting the GPS Global Safety Leadership (GSL) team, collaborating with clinical, medical, and regulatory teams, and communicating with business partners and distributors regarding safety data exchange agreements. Additionally, the manager will assign tasks to Safety Specialists, identify areas for improvement, and develop new processes and procedures. To qualify, candidates must have a Bachelor's or Master's degree in nursing, healthcare, or a related life-science field, along with a minimum of 5 years of relevant experience in safety, clinical research, or pharmacovigilance. At least 7 years of experience in global pharmacovigilance, specifically in the EU and US, is required. Proficiency in safety database systems, particularly ARGUS, and advanced knowledge of global pharmacovigilance requirements and practices are essential. Strong communication skills in English, both written and spoken, are also mandatory. Nice-to-have skills include experience with Health Authority inspections and proficiency in Microsoft Office, including Excel, PowerPoint, and Visio. The role is based in Belgium, Switzerland, or the US (EST time zone), and candidates must be located in one of these areas to be considered. The position offers the opportunity to participate in both short-term and long-term incentives programs. What the role asks for: - Bachelor's or Master's degree in nursing, healthcare, or a related life-science field. - 5 years of relevant experience in Safety, Clinical Research, or Pharmacovigilance. - 7 years of relevant experience in global pharmacovigilance (EU & US). - Advanced expertise of global (EU/US) pharmacovigilance requirements and practices. - Advanced experience with safety database systems (ARGUS preferred) including workflow management. - Proven experience in interaction with 3rd party vendors. - Proven experience with the identification of quality issues and evaluation of quality metrics. - Advanced communication in written and spoken English.