Senior Medical Director, Drug Safety and Pharmacovigilance
Senior Medical Director, Drug Safety and Pharmacovigilance
Dianthus Therapeutics, Inc.
Waltham, MA
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Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
As the Senior Medical Director, Drug Safety and Pharmacovigilance, you will be responsible for leading, developing, and executing our drug safety and pharmacovigilance strategy.
Reporting to the Head of Safety, the Senior Medical Director, Drug Safety will lead pharmacovigilance activities including the analysis of safety data, identifying, detecting and investigating safety signals, evaluating and proactively managing risk, and providing medical safety review of Dianthus products. Building relationships with internal and external stakeholders, you will oversee the development of safety periodic reports and perform medical review of individual case safety reports. You will also be responsible for supporting all safety activities for all clinical trials including but not limited to working with our DSMB, reviewing protocols and risk / benefit analysis for IBs, etc. Previous experience overseeing drug safety and pharmacovigilance activities is critical to be successful in this role.
This is an exciting opportunity to join a clinical-stage biotech and have significant impact. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely.
Key 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
- 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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Seniority level
Director -
Employment type
Full-time -
Job function
Health Care Provider -
Industries
Technology, Information and Internet
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