Associate Director, Pharmacovigilance

Dianthus Therapeutics

Remote, United States
**
Pharmd or rn degree required
Review adverse events and saes
Support dsmb and src meetings
** Dianthus Therapeutics is seeking an Associate Director of Pharmacovigilance to oversee safety data management and regulatory compliance in clinical trials. The role requires experience in pharmacovigilance activities, specifically in reviewing adverse events and collaborating with cross-functional teams. **

Job Summary

  • This role is critical in ensuring patient safety and regulatory compliance throughout the drug development lifecycle.
  • You will work closely with safety physicians, clinical teams, and external stakeholders to manage safety data and contribute to safety oversight.
  • The company is building a culture focused on elevating the care of patients' lives while developing best-in-class therapies for severe autoimmune diseases.

Matching Summary

Match Score: 75

** Dianthus Therapeutics is seeking an Associate Director of Pharmacovigilance to oversee safety data management and regulatory compliance in clinical trials. The role requires experience in pharmacovigilance activities, specifically in reviewing adverse events and collaborating with cross-functional teams. **

Skills & Requirements

Must-have

  • PharmD or RN degree required
  • Review adverse events and SAEs
  • Support DSMB and SRC meetings
  • Fluency with Argus safety database
  • Knowledge of FDA EMA ICH guidelines

Nice-to-have

  • Experience in rare disease programs
  • Prior start-up environment experience
  • Familiarity with oncology programs
  • Strong analytical and organizational skills
  • Ability to thrive in fast-paced setting

Key Requirements

  • PharmD or RN degree
  • Experience in biotech/pharma industry
  • Hands-on DSMB and SRC support
  • Proficiency in Microsoft Office Suite
  • Global PV regulations knowledge

Work Rights

Must be authorized to work in the United States

Tailored Resume

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