Work Flexibility: Remote
Staff Clinical Safety Specialist – Remote
As a Staff Clinical Safety Specialist, you will serve as a clinical safety subject matter expert across multiple studies, leading safety event review, adjudication, reporting, and process oversight while partnering with cross-functional teams to support consistent and compliant clinical study execution.
This role combines clinical safety expertise, regulatory knowledge, and operational leadership to ensure accurate assessment, documentation, coding, and reporting of clinical safety events across a global study portfolio.
Work Flexibility:
- Remote
What You Will Do
- Lead clinical safety oversight activities across assigned studies, including identification, assessment, adjudication, and reporting of adverse events and other safety-related events.
- Review and evaluate adverse events, serious adverse events, protocol-defined endpoints, and other safety signals to ensure accurate and timely documentation and escalation.
- Author and review clinical event narratives, ensuring completeness, consistency, scientific accuracy, and regulatory compliance.
- Partner with Clinical Operations, Medical Affairs, Data Management, Biostatistics, Regulatory Affairs, and Quality teams to support timely safety event review, reporting, and resolution.
- Coordinate with clinical sites, contract research organizations, field monitors, medical monitors, and adjudication committees to obtain and reconcile source documentation required for safety assessments.
- Perform and oversee clinical safety event coding activities using established coding standards and conventions to maintain data quality and consistency.
- Present safety findings, event summaries, adjudication outcomes, and emerging trends during safety review meetings and governance forums.
- Drive continuous improvement initiatives that enhance safety processes, inspection readiness, data quality, compliance, and operational efficiency across studies.
What You Will Need
Required Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related discipline.
- Minimum 4 years of experience in clinical research, clinical safety, pharmacovigilance, medical device vigilance, or a related field.
- Working knowledge of Good Clinical Practice (GCP), U.S. Food and Drug Administration (FDA) regulations, ISO 14155, International Council for Harmonisation (ICH) guidelines, and Medical Device Reporting requirements.
- Experience assessing and documenting adverse events, serious adverse events, and other clinical safety events within regulated clinical studies.
Preferred Qualifications
- Advanced degree in Life Sciences, Nursing, Pharmacy, Public Health, Medicine, or a related scientific discipline.
- Experience supporting clinical event adjudication committees, data safety monitoring boards, or medical monitoring activities.
- Experience with Medical Dictionary for Regulatory Activities (MedDRA) coding and clinical safety databases.
United States of America Pay Ranges:
- USN: $95,700 – $159,500 USD Annual
- US5: $100,500 – $167,500 USD Annual
- US10: $105,300 – $175,500 USD Annual
- US15: $110,100 – $183,400 USD Annual
- US20: $114,800 – $191,400 USD Annual
- US30: $124,400 – $207,400 USD Annual