Clinical Trial Safety Specialist
1 week ago
Job Overview
This Clinical Trial Safety Specialist plays a pivotal role in the Clinical Trial Patient Safety Organization, dedicated to the evaluation and assurance of clinical trial patient safety data. The focus is on the consistent and precise delivery of high-quality, relevant, and timely data reviews.
This position fosters a culture of continuous improvement, innovation, and collaborative teamwork, aligning with AbbVie's vision and strategic objectives.
The role contributes to global monitoring of clinical trial patient safety data and ongoing enhancement initiatives.
Key Responsibilities:
- Conduct timely evaluations of reported clinical trial data and engage in relevant safety surveillance activities for assigned studies, including the review and contribution to necessary ad-hoc Safety Reports.
- Analyze safety-related data from clinical trials for content, quality, potential trends at the study level, and compliance with regulatory guidelines and protocols, employing critical thinking skills.
- Maintain a constant state of audit readiness for study deliverables.
- Oversee safety-related inquiries directed to Investigators.
- In collaboration with the medical monitor, strategize and implement the study safety review plan.
- Provide safety insights to the clinical team, Clinical Research Organizations, Investigators, and investigator sites as required.
- Participate in the evaluation of study protocols to ensure the inclusion of appropriate safety language.
- Review safety sections of clinical study reports and other ad-hoc reports that encompass safety data.
- Draft narratives for serious adverse events and other significant occurrences in accordance with established standards.
- Stay informed about ICH, FDA, and EMA regulatory guidelines that impact safety surveillance.
- May contribute to departmental process improvement initiatives.
- Support the department, division, and company's strategic direction by exemplifying AbbVie's "Ways We Work" leadership behaviors.
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