Global Medical Safety Lead

argenx BV; Belgique; Remote; EUR 140,000 - 200,000; Full time

Job summary

argenx, a global immunology company, is seeking a senior medical safety leader to oversee safety assessments and risk-management for its diverse portfolio.

Reporting to the Head of Global Patient Safety, you will collaborate with Regulatory Affairs, clinical development, and medical affairs to align safety communications, prepare regulatory safety sections, and drive governance of pharmacovigilance activities worldwide.

Qualifications

• MD degree or equivalent required.
• At least 15 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus).
• At least 1 year of experience in clinical practice or in academic medicine.
• 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.

Responsibilities

• Provide strategic medical safety leadership 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 regulatory submissions (ISS, SCS, narratives).
• Prepare and/or review safety sections of clinical/regulatory documents (study protocols, IBs, Clinical Study Reports, or ICFs).
• Provide medical safety support for responses to regulatory authority inquiries; ensure safety information is timely and accurate.
• Lead the preparation of periodic safety reports (PSUR, DSUR) and ensure consistency and quality of these documents.
• Oversee medical assessment of individual case safety reports (ICSR).
• Confirm criteria and content for expedited reporting and unblinding (SUSARs).
• Lead or contribute to safety presentations to the Data Safety Monitoring Board (DSMB).
• Provide medical safety contributions at internal audits and regulatory inspections.
• Support GPS SOPs and other controlled documents; participate in cross-functional initiatives.

Skills

Scientific skills

Analytical thinking

Cross-functional leadership

Presentation skills

MS Office

English fluency

Education

MD degree

Job description

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

Lead and perform the assessment of medical safety data for assigned products
Develop and execute safety signalling 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 products

REPORTING LINE

Report to the Head of Global Patient Safety

ROLES 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 unblinding (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. work instructions, forms, templates)
• Support adverse event reporting training and pharmacovigilance awareness activities cross functionally
• Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners
• Participate in cross-functional teams and initiatives
• All other responsibilities as required

SKILLS AND COMPETENCIES

• Strong scientific and analytic skills
• Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment
• Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams
• Excellent presentation skills with the ability to communicate complex issues clearly
• 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 15 years of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus)
• At least 1 year of experience in clinical practice or in academic medicine
• 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.

undefined Note: 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. This job is eligible to participate in our short-term and long-term incentives program. The 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.

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 [e-mail].

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 bold2030 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.

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.