Clinical Safety Analyst

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Contribute to the global monitoring of clinical trial patient safety data and ongoing improvement initiatives.

• Evaluate reported clinical trial data promptly.

• Engage in safety surveillance activities for designated studies.

• Review and assist in the preparation of ad-hoc safety reports.

• Analyze clinical trial safety data for content, quality, study-level trends, and compliance with regulatory guidelines and protocols.

• Ensure audit readiness for study deliverables.

• Oversee safety-related inquiries directed to investigators.

• Work in collaboration with the medical monitor to plan and carry out study safety evaluations.

• Provide safety summaries to clinical teams, clinical research organizations, investigators, and investigative sites.

• Take part in study protocol assessments to confirm appropriate safety language usage.

• Review safety sections of clinical study reports and various ad-hoc safety data reports.

• Draft serious adverse event narratives and other significant event narratives following accepted standards.

• Participate in departmental process enhancement initiatives.

• Support AbbVie’s strategic objectives through its “Ways We Work” leadership practices.

⛳️ Requirements

• Bachelor’s degree in a relevant health science discipline.

• RN or clinical pharmacy experience is highly preferred.

• At least 2 years of relevant experience, including a minimum of 2 years in clinical practice.

• Ideally, 1 year of experience in drug safety associated with clinical trial lifecycle management from pre-clinical through Phase III and market launch.

• Proficiency in computer applications, including Windows, Word, and Excel.

• Familiarity with specific databases, such as Oracle/Clinical, PIMS, and laboratory databases.

• Ability to critically assess medical data, encompassing clinical courses and treatment approaches.

• Strong communication skills for conveying study-related information effectively.

• Up-to-date knowledge of ICH, FDA, and EMA regulatory guidelines impacting safety surveillance.

🏝️ Benefits

• Paid time off (including vacation, holidays, and sick leave).

• Comprehensive medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Option to work remotely.