Safety Evidence

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 Safety Evidence (Medical) Lead generates insights relevant for argenx products and competitors with focus on safety. This may include the identification, collection, integration, and evaluation of data from various external sources including internal safety database, external health data, PAS, medical literature or others.

This role combines medical/scientific expertise, data analytics, and strategic thinking to ensure understanding of safety profile of our products as well as communicating insights to various stakeholders. Deep understanding of the safety profiles and the science of our products and emerging trends in the relevant competitor safety profile(s) is a must for this role.

Preferred locations: Belgium, Switzerland, East Coast US
Purpose Of The Function

• She/he will work closely with other Safety Evidence team members and well as other internal and external stakeholders and other decision makers to identify evidence gaps, and collaborate on development and execution of Integrated Evidence Generation Plans (IEGPs) in support of argenx innovative therapies.
• Acting as a key safety resource for non-safety functions, she/he will analyze safety data from various sources, and effectively communicate key findings to relevant stakeholders. This role involves collaboration across functional areas, presenting safety-relevant information, and engaging with external stakeholders, including key opinion leaders (KOLs).
• She/he will lead safety-related studies and be the key contact person for safety questions on other RW studies.
• He/she will report to the Head of Safety Evidence Generation and will closely collaborate with colleagues in Global and Regional Cross Functional Teams from Medical Affairs including RWE, Regulatory, Biostatistics, GPS, Clinical Development and others as needed.

Roles And Responsibilities

• Monitor the emerging safety profile of our products in comparison to competitor safety profile(s) to understand differentiating aspects, and identify evidence gaps on safety. Utilize analytical methods to interpret safety data from various sources, in order to generate relevant insights.
• Work with key functional areas (RWE, Medical Affairs, GPS, Regulatory, HEOR, Clinical Development, Clinical Science) on the development of Integrated Evidence Generation Plans (IEGPs), including the planning, prioritization, and execution of real-world studies, with particular focus on safety aspects and outcomes.
• For safety-related PASS studies, lead the planning and protocol development, data analyses as well as development of scientific messages and dissemination of data in collaboration with any relevant internal or external stakeholders including vendors.
• Oversee safety of all of the participants in PASS studies as well as review all PASS reports for inclusion of the correct information that is warranted.
• Serve as the primary medical safety resource for all relevant stakeholders in RWE, Medical Affairs and other relevant functional areas with respect to evaluation of all factors that may impact safety, all safety endpoints and safety data interpretation on real-world studies and data in order to obtain meaningful outcomes supporting products in development as well as those marketed by argenx.
• Clearly and effectively communicate safety findings internally and externally promptly with all relevant stakeholders.
• Collaborate with Scientific Communications on integrated publication plans for safety evidence.
• Foster an environment of continuous learning/improvement with all internal/external stakeholders. Function as an argenx ambassador for engaging with external stakeholders such as KOLs.
• Attend relevant internal and external meetings for training, competitor intelligence, and collaboration with KOLs and other experts.

Skills And Competencies

• Collaborative with strong communication, interpersonal, and leadership skills and a proven track record of working and communicating effectively within a complex multi-disciplinary environment.
• Strong active listening skills with ability to incorporate input from a variety of internal and external stakeholders. Communicates routinely and clearly with relevant stakeholders and maintains visibility to meet relevant objectives, strategies and tactics.
• Drives initiative with ability to work with minimal supervision.
• Proactive with good organizational skills and "hands on" attitude, reliable and solution oriented.
• Effective in setting clear priorities among competing activities. Leverages experience and know-how to focus on priority objectives.
• Highly developed analytical skills to understand complex matrix linkages of safety data from various sources.
• Demonstrates an ability to manage multiple projects simultaneously and adapt to changing priorities in a fast-paced environment. Skilled in building strong relationships with cross-functional teams and external partners to drive collaborative efforts and achieve common goals.
• Embraces innovation by constantly seeking new ways to get results in different situations.

Education, Experience And Qualifications

• Medical Degree preferred. PhD, PharmD, or similar degree acceptable.
• Experience in gynaecology/obstetrics or experience assessing safety in pregnancy
• Strong medical/scientific background, inspired by prioritizing patient safety. Good knowledge of pharmaceutical drug development (clinical development and/or medical affairs) and compound safety generation/evaluation activities.
• Min 10 years leading scientific / clinical projects or studies.
• Good working knowledge of both GCP and GVP.
• Ability to travel up to 10-20% of time as needed

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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