Global Medical Safety Lead

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🔥 1 minute ago

🌐 Belgium, Switzerland, +1 more countries – Remote

🇧🇪 Belgium – Remote 🇨🇭 Switzerland – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• Lead and perform assessment of medical safety data for assigned products • Develop and execute safety signalling and benefit-risk management strategies • Collaborate with internal stakeholders and external key opinion leaders or regulatory agencies • Provide strategic medical safety leadership and practical contributions in cross-functional settings • Perform safety signal management, benefit-risk assessments, and aggregate safety data reviews • Lead cross-functional reviews of existing and emerging aggregate safety data • Contribute to safety governance structures and activities • Provide safety contributions for global regulatory submission documents • Prepare and review safety sections of clinical and regulatory documents • Support responses to regulatory authority inquiries • Lead preparation of periodic safety reports and ensure their consistency and quality • Oversee medical assessment of individual case safety reports • Confirm criteria and content for expedited reporting and unblinding • Lead or contribute to safety information preparation and presentations to the Data Safety Monitoring Board • Provide medical safety contributions during internal audits and regulatory inspections • Support development and updates of pharmacovigilance SOPs and controlled documents • Support adverse event reporting training and pharmacovigilance awareness activities • Support preparation of pharmacovigilance agreements with clinical development or commercial partners • Participate in cross-functional teams and initiatives • Report to the Head of Global Patient Safety

🎯 Requirements

• MD degree or equivalent required • At least 15 years of relevant experience in the pharmaceutical/biotech industry • At least 5 years of experience in pharmacovigilance/drug safety • At least 1 year of experience in clinical practice or 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 authoring complex documents and contributing to regulatory submissions • Knowledge of adverse event reporting systems • Strong scientific and analytic skills • Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment • Ability to lead, motivate, influence, and collaborate with multidisciplinary teams • Excellent presentation skills and ability to communicate complex issues clearly • Proficiency with Microsoft Office • Fluency in written and spoken English • Candidates must be located in Belgium, Switzerland, or the United States (EST time zone) • Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus • Global experience is a plus

🏖️ Benefits

• Short-term incentives program • Long-term incentives program • Equal consideration for employment without discrimination • Inclusive work environment