On-Site Clinical Safety Specialist: Detail‑Driven AE Expert

Custom Search Inc.; Maple Grove (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Custom Search Inc. in Minnesota is seeking a Clinical Safety Specialist to support an investigational heart valve program. This is an execution-heavy on-site role, not strategy, and you’ll be hands-on day-to-day to ensure safety data stays clean and compliant.

You’ll process adverse events (AEs and SAEs) end-to-end, review source docs, write safety narratives, and help with regulatory reporting and inspection readiness. Collaboration with Clinical, Regulatory, and Data teams onsite is constant.

Qualifications

• Bachelor’s degree and Engineering or Chemistry preferred.
• Understanding of medical and clinical terminology.
• Understanding of HIPAA and patient privacy regulations.
• Must be a flexible team player to balance independent work with collaborative project execution.
• Strong adherence to study protocol, SOPs, FDA regulations.

Responsibilities

• Processing AEs and SAEs end-to-end.
• Reviewing source docs and chasing down missing data.
• Writing safety narratives and supporting regulatory reporting.
• Keeping everything inspection-ready at all times.
• Working closely with Clinical, Regulatory, and Data teams onsite.

Education

Bachelor’s degree, Engineering or Chemistry preferred

Job description

Custom Search Inc. in Minnesota is seeking a Clinical Safety Specialist to support an investigational heart valve program. This is an execution-heavy on-site role, not strategy, and you’ll be hands-on day-to-day to ensure safety data stays clean and compliant.

You’ll process adverse events (AEs and SAEs) end-to-end, review source docs, write safety narratives, and help with regulatory reporting and inspection readiness. Collaboration with Clinical, Regulatory, and Data teams onsite is constant.