Drug Safety Specialist (Medtech)

TL;DR

Drug Safety Specialist (Medtech): Managing serious adverse event case processing and safety reporting for clinical trials with an accent on regulatory compliance and database management. Focus on ensuring accurate data entry, medical coding, and timely reporting in accordance with FDA and ICH guidelines.

Location: Must be based in the United States

Salary: $75,600 - $113,400 USD

Company

hirify.global is a specialized services company supporting the development and commercialization of life-changing therapies.

What you will do

• Manage serious adverse event (SAE) case processing from intake to regulatory reporting.
• Perform data entry, medical coding, and expectedness assessments for individual case safety reports.
• Collaborate with sponsors and internal teams to design safety collection tools and reporting systems.
• Prepare and review project-specific safety reporting plans and medical coding plans.
• Provide safety training and oversight for consultants and staff.
• Draft and review standard operating procedures and work instructions.

Requirements

• Must be based in the United States
• BA/BS degree required
• Minimum 2 years of safety experience
• Health care professional background
• Hands-on experience with global safety databases and SAE case processing
• Working knowledge of MedDRA, WHODrug, FDA safety regulations, and ICH guidelines

Nice to have

• Nursing or pharmacy degree
• Clinical trial safety experience
• Hands-on experience with Argus
• Industry experience in a CRO or pharmaceutical company

Culture & Benefits

• Comprehensive health insurance and retirement savings benefits
• Discretionary annual bonus
• Paid time off for sick leave and vacation
• Parental leave and life/disability insurance