Clinical Safety Analyst - Remote

Overview

This Clinical Safety Analyst supports the Clinical Trial Patient Safety Organization to achieve its mission of evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery of high-quality relevant and timely data review.

In Short

• Provides timely assessment of reported clinical trial data.
• Participates in safety surveillance activities for assigned studies.
• Maintains constant state of audit readiness for study deliverables.
• Collaborates with medical monitors for study safety reviews.
• Reviews safety-related data for content and quality.
• Creates narratives of serious adverse events.
• Current with ICH, FDA, and EMA regulatory guidance.
• Supports process improvement projects.
• Delivers safety overview to clinical teams and investigators.
• Ensures appropriate safety language in study protocols.

Requirements

• Bachelor's degree with a health science background.
• 2+ years of clinical practice experience.
• RN or clinical pharmacy experience preferred.
• Drug safety experience with clinical trial lifecycle management.
• Proficiency in Windows, Word, Excel, and specific databases.
• Ability to critically evaluate medical data.
• Effective communication skills.

Benefits

• Comprehensive benefits package including paid time off.
• Medical/dental/vision insurance.
• 401(k) participation for eligible employees.
• Participation in short-term incentive programs.