Medical Director – Global Drug Safety, Pharmacovigilance
Job Description:
• Accountable for pharmacovigilance and drug safety activities for Phase I - IV clinical studies
• Provide safety input for regulatory documents
• Support clinical development teams with safety monitoring
• Prepare and review safety reports and clinical documents
• Lead evaluation & management of signals from any data source
• Contribute to safety labeling activities for BioCryst products
• Maintain knowledge of regulations, ICH guidelines, and industry practices
• Attend team and safety governance meetings, may require travel
Requirements:
• MD or equivalent
• At least 5 years of Drug Safety experience required
• Knowledge of GVP, ICH-GCP, and regional regulatory PV requirements
• Critical thinker and strong interpersonal skills
• Excellent writing and oral communication skills in English
• Ability to work with others at all levels and from diverse backgrounds
• Ability to manage multiple projects and maintain timelines
• Competence with standard office computer software tools
Benefits:
• Innovation and accountability culture
• Engagement and achievement rewards
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