Drug Safety Specialist II

Job Summary

Providing safety expertise and managing serious adverse event (SAE) case processing, the remote Drug Safety Specialist II will develop safety management plans, interface with sponsors and vendors, and ensure compliance with regulatory reporting requirements.

Key responsibilities

• Develop and implement safety collection tools, processes, and reporting systems in collaboration with internal teams and sponsors
• Manage SAE case processing, including intake, triage, medical coding, and preparation of individual case safety reports (ICSRs)
• Prepare and review project-specific safety reporting plans and provide safety training to staff and consultants

Required qualifications

• BA/BS degree
• Minimum of 2 years of safety experience
• Health care professional with hands-on experience in global safety databases and SAE case processing
• Working knowledge of MedDRA, WHODrug, FDA safety regulations, and ICH guidelines
• Experience in drafting standard operating procedures and safety training materials