Staff Clinical Safety Specialist - 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.
• Cook up and reconcile source documentation required for safety assessments.
• 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.

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.