Global Medical Safety Lead
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Job Description
Global Medical Safety Lead overseeing pharmacovigilance and safety strategies for argenx’s immunology medicines. Leading regulatory submissions, signal management, and cross-functional medical safety activities.
Responsibilities:
- 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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