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 Apply tot his job