Drug Safety Physician

3 days ago


Watertown, Massachusetts, United States Dragonfly Therapeutics, Inc. Full time
Job Summary

We are seeking a highly skilled Drug Safety Physician to join our team at Dragonfly Therapeutics, Inc. This is a critical role that will be responsible for ensuring the safety of our clinical trials and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Manage all aspects of drug safety and pharmacovigilance, including leadership of safety data review, signal detection, risk communication, and mitigation of potential risks.
  • Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of SAEs.
  • Work with cross-functional teams to ensure timely and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines.
  • Develop and implement safety protocols and procedures to ensure compliance with regulatory requirements.
  • Collaborate with vendors and internal stakeholders to ensure effective safety monitoring and reporting.
Requirements
  • MD required, with a minimum of 7 years in drug safety related activities in pharma/biotech.
  • Clinical trial experience, including oncology drug safety with at least 3 years being in early clinical development.
  • Experience authoring, reviewing, and providing input to drug-safety related regulatory reports.
  • Strong knowledge of FDA, EU, ICH, and other global regulatory requirements for safety reporting and safety data and risk management.
  • Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring.
About Dragonfly Therapeutics, Inc.

Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients.



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