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Associate Director, Pharmacovigilance
Dianthus Therapeutics, Inc.Associate Director, Pharmacovigilance at Dianthus Therapeutics ensuring patient safety during clinical trials and supporting safety data management with a growing team.
About the role
Key responsibilities & impact- Work closely with the Safety team to support ongoing clinical trials.
- Ensure patient safety and regulatory compliance throughout the drug development lifecycle.
- Manage safety data and contribute to safety oversight.
- Review adverse events, safety signals, and coordinate/contribute to SRC and DSMB meetings.
- Work collaboratively with the pharmacovigilance team and cross-functional teams.
Requirements
What you’ll need- Education: PharmD or RN degree required.
- Experience in pharmacovigilance or in clinical development within biotech or pharmaceutical industry.
- Proven experience reviewing adverse events and working closely with safety physicians.
- Hands-on experience supporting DSMBs and SRCs and preparing safety deliverables.
- Proficiency in Microsoft Office Suite and Microsoft Teams, with the ability to leverage these tools for efficient communication, scheduling, and documentation
- Strong knowledge of global PV regulations (FDA, EMA, ICH guidelines).
- Excellent analytical, organizational, and communication skills.
- Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
- Fluency with Argus safety database
- Familiarity with rare disease or oncology programs.
- Prior experience in a start-up or small biotech setting.
Benefits
Comp & perks- remote within the United States
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilanceclinical developmentadverse events reviewsafety oversightsafety deliverables preparationglobal PV regulationsArgus safety databasebiotech industry experiencepharmaceutical industry experienceanalytical skills
Soft Skills
organizational skillscommunication skillsability to manage multiple prioritiescollaborative skillsability to thrive in fast-paced environments
Certifications
PharmDRN degree