Senior Clinical Safety Analyst

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose:

This position 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. Contributes to a culture of process improvement, innovation, and cross-
functional teamwork aligning with the company vision and strategies.

Responsibilities:

This position is responsible for world-wide surveillance of clinical trial patient safety data and continuous improvement efforts.

Core Job Responsibilities include:

• Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review and contribution to ad-hoc Safety Reports as needed.
• Provide independent review and analysis of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.
• Aligns and maintains effective communication channels with key clinical, medical, study team, including CTPS manager, regulatory, compliance, and pharmacovigilance counterparts.
• Maintains constant state of audit readiness for study deliverables.
• Supervises the tracking of safety-related queries to Investigators, ensuring appropriate closure.
• In collaboration with medical monitor, plans and executes the plan for study safety review.
• Provides safety overview to the clinical team, Clinical Research Organizations, Investigators and investigator sites as needed.
• Participates in review of study protocols to ensure a