Safety Lead

Job Summary

To support safety initiatives in clinical trials, the remote Safety Lead will manage safety budget reviews, develop safety management plans, and oversee serious adverse event case management while providing expertise to team members and clients.

Key responsibilities

• Interface with sponsors and vendors to design and implement safety collection tools and reporting systems
• Prepare and review project-specific safety reporting plans and manage standard operating procedures
• Provide ongoing training and mentorship for Safety Specialists and participate in audits and regulatory agency inspections

Required qualifications

• BA/BS degree
• 10+ years of clinical safety experience
• 5+ years of pharmacovigilance (PV) experience
• Hands-on experience with global safety databases and SAE case processing
• Working knowledge of FDA safety regulations and ICH guidelines