Dianthus Therapeutics, Inc. · 2 months ago
Medical Director, Drug Safety and Pharmacovigilance
United States
Full-time
Remote
Lead/Staff, Director/Executive
3+ years expDianthus Therapeutics is developing innovative therapies for patients with severe autoimmune diseases. The Medical Director, Drug Safety and Pharmacovigilance will ensure the safety of investigational products, conducting pharmacovigilance analyses, risk management, and collaborating across functions to maintain compliance and operational excellence.
BiopharmaBiotechnologyHealth Care
Responsibilities
Serve as the safety physician lead for designated Dianthus’s product
Conduct medical review of individual case safety reports (ICSRs), including seriousness, expectedness, and causality assessment, ensuring appropriate coding and compliance with global regulations
Perform aggregate data analysis and interpretation
Author and provide medical input to safety related regulatory documents such as periodic safety reports (e.g., DSURs, ASRs, PSUR, PADERs, etc.) or other deliverables as appropriate
Contribute to / lead safety review committee activities, including individual and aggregate data analyses, signal detection and evaluation, interpretation of safety signals and trends, and documentation and communication of safety assessments
Contribute to relevant clinical and regulatory documents, such as study protocols, investigator brochures, statistical analysis plan, and clinical study reports
Collaborate with relevant functions such as clinical development, data management, regulatory affairs, biostatistics, and medical affairs on relevant safety issues
Review and summarize relevant scientific and clinical literature to support safety evaluations and regulatory submissions
Support the senior medical director / designee on complex pharmacovigilance tasks/activities such as integrated safety analyses, benefit–risk assessments, and development of risk management strategies
Support internal and external pharmacovigilance audits and regulatory inspections
Collaborate closely with the pharmacovigilance scientist and operation to ensure high-quality case processing, database oversight, compliance monitoring, and preparation of relevant safety deliverables
Stay current with global pharmacovigilance regulations, guidelines, and best practices
Additional tasks as needed
Qualification
Required
MD, DO, or U.S. equivalent required
At least 3 years of industry pharmacovigilance (PV) experience as a safety physician
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/ Ability to build strong relationships with co-workers of various backgrounds and expertise
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Ability to prioritize, respond to directives, and work in a fast-paced and changing environment remotely
Get-it-done-roll-up-your-sleeves attitude and commitment to putting patients first
Leadership skills, including a collaborative and team-oriented approach
Ability to function independently at a high level in a team setting, whether leading the group or acting as an individual contributor
Trustworthy with the highest level of integrity; committed to ethics and science standards
Preferred
Experience in neurology, immunology, and rare disease
Experiences in early and late phase clinical trials
Company
Dianthus Therapeutics, Inc.
Dianthus Therapeutics, Inc.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$639.5M2025-09-09Post Ipo Equity· $288M
2024-01-22Post Ipo Equity· $230M
2023-09-12IPO
Leadership Team
Marino Garcia
President & Chief Executive Officer, Board Member
Ryan Savitz
Chief Financial Officer
Recent News
Clinical Trials Arena
2025-12-25
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