About

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. PURPOSE OF THE FUNCTION The Safety Risk Management Lead provides safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). S/he will perform ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources. ROLES AND RESPONSIBILITIES Lead safety signal management activities including data preparations and presentations. Assist GPS GSLs in their assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders internally. Prepare data for and actively participate in safety governance and risk management processes including safety management teams (SMT) and benefit-risk committees (BRC). Effectively lead, oversee and participate in the planning, preparation and review of periodic reports (DSUR, PSUR, PADER). Participate in the presentation and analysis of safety data from on-going and completed clinical trials. Review and provide safety input, as needed, for key study-related documents, e.g., Investigator’s Brochure (IB), Informed Consent Form (ICF), Independent Data Monitoring Committee (IDMC) Charter. Participate in protocol development and review, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans, as needed. Participate in departmental development activities including SOP and Work Instructions development. Perform other activities as needed to assist with departmental activities. SKILLS AND COMPETENCIES 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 Ability to prepare and/or review high quality safety documents, including periodic aggregate safety reports, signal evaluation report, or risk management plans. Ability to communicate complex issues effectively Ability to influence and collaborate with multidisciplinary teams Ability to prioritize and plan proactively Excellent analytical and problem-solving skills, with sound autonomy and applied judgment Experience with MedDRA, WHO Drug Dictionary Understanding of the principles of databases, querying data sources as well as developing and applying search strategies Relevant computer skills including proficiency with Microsoft Office Fluency in written and spoken English EDUCATION, EXPERIENCE AND QUALIFICATIONS Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences or technical fields (Ph. D. or M.D a plus) Minimum of 7-10 years of relevant pharmaceutical/biotech industry or healthcare experience Pharmacovigilance/safety risk management experience is strongly preferred 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. Before 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 privacy@argenx.com. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.