Global Medical Safety Lead

🔥 0 minutes ago

🌐 Belgium, Switzerland – Remote

🇧🇪 Belgium – Remote 🇨🇭 Switzerland – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 33 days.
• No salary listed.

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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 medical safety data assessments 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 • Prepare 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 document 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 prepared for Data Safety Monitoring Boards • Provide medical safety contributions during 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 partners • Participate in cross-functional teams and initiatives

🎯 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 • Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams • Excellent presentation skills and ability to communicate complex issues clearly • Relevant computer skills, including proficiency with Microsoft Office • Fluency in written and spoken English

🏖️ Benefits

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

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