Remote Safety Data Specialist - MedTech Compliance

North American Science Associates, Inc.; Northwood (OH); Hybrid; USD 56,000 - 109,000; Full time

Job summary

NAMSA seeks a Safety Specialist to manage ICSR intake, review, and data entry, ensuring accurate narratives and follow-up data. You will coordinate CEC and DMC activities, collaborate with study teams, and help maintain Safety SOPs and training materials.

The role requires a life sciences degree and at least 1 year in safety reporting or ICSR processing, with strong medical terminology knowledge and proficiency in EDC systems and Microsoft Office.

Qualifications

• Bachelor's degree in Life Sciences or RN/PharmD required, with a preference for regulatory or clinical safety background.
• At least 1 year of experience in CEC, DMC, Safety reporting and ICSR processing desired.
• Experience and use of EDC/database systems required.
• Strong knowledge of medical terminology and industry acronyms.
• Excellent written and verbal communication with detail-oriented approach.
• Proficient with Microsoft Office and data entry conventions.

Responsibilities

• Promote operational excellence by monitoring and improving ICSR, CEC, and DMC processes.
• Perform intake, review, analysis, and data entry of ICSRs; write narratives and determine required follow-up data.
• Distribute ICSR notifications to study teams and sponsor; participate in ICSR reconciliation.
• Maintain SOPs, guidelines, templates, and training materials for Safety.
• Mentor junior Safety staff and co-author safety project documents.
• Prepare aggregate Safety reports and assist in Trial Master File maintenance.

Skills

Attention to detail

Documentation

Communication

Microsoft Office

EDC systems

Safety terminology

Team collaboration

Education

Bachelor's degree in Life Sciences or RN/PharmD

Tools

EDC database

Safety database

MedDRA dictionary

Job description

NAMSA seeks a Safety Specialist to manage ICSR intake, review, and data entry, ensuring accurate narratives and follow-up data. You will coordinate CEC and DMC activities, collaborate with study teams, and help maintain Safety SOPs and training materials.

The role requires a life sciences degree and at least 1 year in safety reporting or ICSR processing, with strong medical terminology knowledge and proficiency in EDC systems and Microsoft Office.