Global Medical Safety Lead
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Job Description
Global Medical Safety Lead guiding pharmacovigilance, safety assessments, and regulatory submissions for argenx’s autoimmune medicines. Leading cross-functional safety governance and benefit-risk strategies.
Responsibilities:
- 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
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