.**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office**Global Medical Safety lead**Purpose of the Function:- Lead and perform the assessment of medical safety data for assigned products- Develop and execute safety signaling and benefit-risk management strategies- Closely collaborate with stakeholders internally (e.G. Regulatory Affairs, clinical development, medical affairs) and externally (e.G. Key Opinion Leaders or regulatory agencies) to align safety communications and to ensure the safe use of argenx productsRoles and Responsibilities:- Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting- Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)- Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)- Contribute to the development of the overall safety governance structure and activities- Provide safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.G. ISS, SCS, narratives) for assigned product(s)- Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)- Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate- Lead the overall preparation of periodic safety reports (e.G. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents- Oversee the medical assessment of individual case safety reports (ICSR)- Confirm criteria and content for expedited reporting and unbinding (e.G. SUSAR or urgent safety issues)- Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)- Provide medical safety contributions at internal audits and regulatory inspections- Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.G