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Associate Director, Pharmacovigilance
Location
United States
Posted
27 days ago
Salary
0
Seniority
Senior
Job Description
Associate Director, Pharmacovigilance
Dianthus Therapeutics, Inc.
• 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.
Job Requirements
- 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
- remote within the United States
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