Senior Clinical Safety Analyst - Remote

Overview

The Senior Clinical Safety Analyst supports the Clinical Trial Patient Safety Organization by ensuring the quality of clinical trial patient safety data through consistent and accurate delivery of high-quality data review.

In Short

• Responsible for world-wide surveillance of clinical trial patient safety data.
• Provides timely assessment of reported clinical trial data.
• Participates in safety surveillance activities for assigned studies.
• Conducts independent review and analysis of safety-related data.
• Maintains communication with clinical and regulatory teams.
• Ensures audit readiness for study deliverables.
• Supervises tracking of safety-related queries to Investigators.
• Creates narratives of serious adverse events.
• Stays current with ICH, FDA, and EMA regulatory guidance.
• Mentors new team members on safety activities.

Requirements

• Bachelor's degree with related health science background.
• Minimum of 4 years of experience, including 2 years of clinical practice.
• 2 years of drug safety experience preferred.
• Proficiency in Windows, Word, Excel, and specific databases.
• Ability to critically evaluate medical data.
• Demonstrated leadership in study management activities.
• Effective communication skills.

Benefits

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