Global Medical Safety Lead

ppJoin 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. /p pWe 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. /p h3Purpose of the Function /h3 pThe Global Medical Safety Lead is the key point of accountability for ensuring the safety of patients and the safe use of assigned argenx products in development and on‑market. The Global Medical Safety Lead leads and performs the assessment of medical safety data and provides strategic medical safety input for the assigned project(s). In this role, the Global Medical Safety Lead is accountable for defining and driving the strategy and approach for the safety activities. Responsibilities include offering expert medical safety contribution and oversight, ensuring comprehensive ownership of safety activities, and leading the assessment of safety data to support informed decision‑making. The role also requires close collaboration with internal stakeholders such as Regulatory Affairs, Clinical Development, and Medical Affairs, as well as external partners including key opinion leaders and regulatory agencies, to align safety communications and ensure the safe and effective use of argenx products. /p h3Reporting Line /h3 ul liReport to the (Asset) Medical Safety Lead /li /ul h3Roles and Responsibilities /h3 ul liProvide strategic medical safety leadership and practical contributions for assigned product(s) in a cross‑functional setting /li liProvide 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) /li liPerform 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) /li liLead cross‑functional teams to perform regular and/or ad‑hoc review of existing and emerging aggregate safety data for assigned product(s) /li liContribute to the development of the overall safety governance structure and activities /li liPrepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs) /li liProvide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate /li liLead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents /li liOversee the medical assessment of individual case safety reports (ICSR) /li liConfirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues) /li liLead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB) /li liProvide medical safety contributions at internal audits and regulatory inspections /li liSupport the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates) /li liSupport adverse event reporting training and pharmacovigilance awareness activities cross functionally /li liSupport the preparation of pharmacovigilance agreements with clinical development or commercial business partners /li liParticipate in cross‑functional teams and initiatives /li liPerform other tasks as required to assist in departmental activities /li /ul h3Skills and Competencies /h3 ul liStrong scientific and analytic skills /li liExcellent ability to interpret and communicate medical safety data from various sources /li liStrong ability to lead, motivate, influence, and collaborate with multidisciplinary teams /li liExcellent presentation skills with the ability to communicate complex issues clearly /li liRelevant computer skills, including proficiency with Microsoft Office /li liFluency in written and spoken English /li /ul h3Education, Experience and Qualifications /h3 ul liMD degree or equivalent required /li liAt least 7 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus) /li liExperience in clinical practice or in academic medicine is a plus /li liWorking knowledge of relevant pharmacovigilance regulatory requirements and guidance documents /li liDemonstrated ability to perform medical assessments of safety data from multiple sources /li liExperience with authoring complex documents and contributing to regulatory submissions /li liKnowledge of adverse event reporting systems /li /ul pCandidates must be located in Belgium, Switzerland or US (EST time zone) to be considered for this role. /p pNote: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location. /p pThis job is eligible to participate in our short‑term and long‑term incentives program. /p pThe hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job‑related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future. /p pAt 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. /p pBefore you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at /p /p #J-18808-Ljbffr