The Associate Director, Pharmacovigilance will work closely with the Safety team to support ongoing clinical trials, ensuring patient safety and regulatory compliance throughout the drug development lifecycle.
Requirements
- PharmD or RN degree required
- Experience in pharmacovigilance or 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
- 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