Remote Senior Medical Director

Summary

Join Dianthus Therapeutics as the Senior Medical Director, Drug Safety and Pharmacovigilance, to lead drug safety and pharmacovigilance strategy. This role involves leading pharmacovigilance activities, analyzing safety data, identifying safety signals, and providing medical safety review of Dianthus products.

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

Responsibilities

• Serves as the safety physician lead for designated Dianthus products
• Conducts medical review of individual case safety reports including coding, seriousness, expectedness, company causality assessment and creates analysis of similar events if applicable
• Performs aggregate safety data review and interpretation to support safety evaluations
• Leads signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments
• Leads safety review committee activities
• Develops and manages risk strategies for Dianthus products
• Authors and provides medical input to safety related regulatory documents such as periodic safety reports (e.g., DSURs, ASRs, PSUR, PADERs, etc.)
• Performs medical review and provides input for drug-safety related regulatory reports and clinical study documents (including but not limited to clinical protocols, investigator brochures, clinical study reports, reference safety information, integrated summary of safety, company core data sheets and informed consent forms)
• Review and summarize scientific literature relevant to Dianthus products and/or pharmacovigilance
• Represents the drug safety and pharmacovigilance department at multidisciplinary product and program team activities
• Stays current with international pharmacovigilance requirements and guidelines
• Other duties as assigned