Senior Medical Director - Drug Safety and Pharmacovigilance
July 25
Description
• Lead drug safety and pharmacovigilance strategy for Dianthus products • Build relationships with stakeholders, oversee safety reports and case reviews • Support safety activities for clinical trials, including working with DSMB and risk analysis • Conduct medical reviews of safety reports and evaluate safety signals • Manage risk strategies and stay current with international requirements
Requirements
• MD or DO required • Neurology experience desired • Strong pharmacovigilance with signal management (e.g., signal detection, evaluation, assessment) • Ability to lead and conduct individual safety case report processing, including triage, medical review and safety data summarization and analysis • Competent knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection • Knowledge of and ability to apply pre- and post-marketing drug safety standards • Proficient with safety databases (Argus preferred) and safety coding dictionaries (e.g., MedDRA, WHODRUG) • Excellent problem-solving, analytical thinking skills • Excellent oral, written and presentation skills • Excellent interpersonal skills and ability to work effectively as part of a team(s) • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
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