Remote Clinical Safety Specialist (US)

Terumo Neuro; California; À distance; USD 120 000 - 160 000; Plein temps

Résumé du poste

Terumo Neuro is seeking a Specialist, Clinical Safety (US Remote) to provide comprehensive clinical safety support for assigned studies. You will review AEs, manage safety committee activities, and draft safety components of study documents.

You will collaborate with Medical Affairs and project teams to ensure timely safety adjudication, regulatory submissions, and risk assessments while maintaining strict confidentiality and regulatory compliance.

Qualifications

• Experience providing clinical safety support to regulated device studies or clinical research.
• Ability to craft high-quality scientific communications and narratives.
• Strong written and verbal communication skills.

Responsabilités

• Provide clinical safety support to assigned studies, including safety documentation and AE review.
• Draft and review clinical safety components of study documents and manuals.
• Review and triage study adverse events and prepare for independent review.
• Schedule and manage safety committees (CECs, DSMBs) and CEAs.
• Support selection and training of physician partners and committee members.
• Generate and present safety committee reports and findings.
• Collaborate with project managers and Medical Affairs to align safety activities with milestones.
• Support regulatory submissions, risk management, and scientific analyses.
• Assist protocol development and adverse event reporting, with investigator support.
• Maintain compliance with laws, regulations, and Quality Management System requirements.
• Perform additional duties as assigned.

Connaissances

Clinical safety

Regulatory knowledge

Scientific communication

Documentation

MS Office

Formation

RN/BSN or equivalent

Outils

MS Office

Description du poste

Terumo Neuro is seeking a Specialist, Clinical Safety (US Remote) to provide comprehensive clinical safety support for assigned studies. You will review AEs, manage safety committee activities, and draft safety components of study documents.

You will collaborate with Medical Affairs and project teams to ensure timely safety adjudication, regulatory submissions, and risk assessments while maintaining strict confidentiality and regulatory compliance.