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. 

The Medical Safety Lead provides strategic medical safety leadership, serving as the single point of contact for all aspects of patient safety. In this role, the Lead is accountable for defining and driving the strategy and approach for communicating safety information across the product(s) lifecycle and projects. 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.

ROLES AND RESPONSIBILITIES

• Provide strategic medical safety leadership and practical contributions in a cross-functional setting

• Participate in cross-functional strategic planning and meetings

• Lead and contribute to the safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews

• 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, responses to regulatory authority inquiries)

• Contribute to and ensure completeness, accuracy and high quality safety sections of clinical documents (including study protocols, IBs, Clinical Study Reports, or ICFs)

• Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents

• Perform the medical assessment of individual case safety reports (ICSR) when required  

• 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. work instructions, forms, templates)

• Support product(s) safety training and pharmacovigilance awareness activities cross functionally

• Lead the development, maintenance, and execution of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)

• Contribute actively to the updates of the safety labelling sections and Core Data Sheets (CDS)

• Provide strategic guidance and have oversight on the case processing activities

• Partner with Safety Operations on case quality issues, MedDRA coding, and case processing convention

• Participate in cross-functional projects and initiatives

• Manage safety physicians as required

• Perform other tasks as required to assist in departmental activities

SKILLS AND COMPETENCIES

• Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams

• Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings

• Knowledge of relevant global pharmacovigilance regulations and guidelines

• Excellent presentation skills with the ability to communicate complex issues clearly

• Strong scientific and analytic skills

• Ability to influence and collaborate with multidisciplinary teams

• Excellent problem-solving skills, with sound autonomy and applied judgment

• Relevant computer skills, including proficiency with Microsoft Office

• Fluency in written and spoken English

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• MD degree or equivalent required

• At least 10 years of relevant experience in the pharmaceutical/biotech industry with at least 7 years in pharmacovigilance/drug safety (global experience is a plus)

• Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence (without having direct reporting lines) and managing complex matrix teams

• Experience in clinical practice or in academic medicine is a plus

• Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents

• Demonstrated ability to perform medical assessments of safety data from multiple sources

• Experience with authoring complex documents and contributing to regulatory submissions

• Knowledge of adverse event reporting systems

• Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus

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This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

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.

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