Staff Clinical Safety Specialist

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

• Bachelors 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: $95700 - $159500 USD Annual
• US5: $100500 - $167500 USD Annual
• US10: $105300 - $175500 USD Annual
• US15: $110100 - $183400 USD Annual
• US20: $114800 - $191400 USD Annual
• US30: $124400 - $207400 USD Annual