Clinical Safety Analyst

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

📋 Description

• Contribute to the global monitoring of patient safety data from clinical trials and efforts for ongoing improvement.

• Evaluate reported data from clinical trials and engage in safety surveillance activities for designated studies.

• Review and analyze safety data from clinical trials for quality, content, study-level trends, and compliance with regulatory guidelines and protocols.

• Ensure audit readiness for study deliverables.

• Oversee safety-related inquiries directed to investigators.

• Plan and conduct safety reviews for studies in conjunction with the medical monitor.

• Provide safety summaries to clinical teams, CROs, investigators, and investigator sites.

• Take part in the review of study protocols to ensure appropriate safety language is included.

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

• Generate narratives for serious adverse events and other notable occurrences.

• Assist in departmental process-improvement initiatives and align with AbbVie’s strategic goals.

⛳️ Requirements

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

• RN or clinical pharmacy experience is highly preferred.

• A minimum of 2 years of experience, which must include at least 2 years in clinical practice.

• Preferred experience of 1 year in drug safety, covering the clinical trial life cycle from pre-clinical phases to Phase III and market launch.

• Proficient in Windows, Word, Excel, and specific databases such as Oracle/Clinical, PIMS, and laboratory databases.

• Capability to critically assess medical data, with an understanding of clinical courses and treatment options.

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

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work culture.