Safety Data Architect Manager

Summary

Join AbbVie's Clinical Trial Patient Safety team as a Safety Data Lead! This role provides strategic and tactical support to the Safety Data Architect and Product Safety Team. You will assist in summarizing potential safety concerns from clinical trial data, contribute to regulatory responses, and ensure data integrity. The position requires expertise in CSA processes, ICH/FDA/EMA regulations, and strong communication skills. This remote-eligible US-based role offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k). AbbVie is committed to diversity and inclusion.

Requirements

• Bachelor's degree with related health science background
• A minimum of 6 years’ experience to include at least 3 years of clinical practice experience and 4 years drug/device safety experience with clinical trial life cycle management – Pre-clinical to Phase III through launch to market
• Proficiency in Computer skills (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases). Ability to lead cross‐functional teams with proven success in results‐driven process management, specifically within clinical trial conduct, operations management for the planning, execution, and reporting of clinical development programs
• Expertise in industry regulations, processes, and clinical safety. Demonstrate excellent interpersonal, leadership, communication and development skills. Ability to establish clear directions/ sets stretching objectives. In depth understanding of product labeling/literature, including safety profile
• Accurately and medically sound presentation of case data, orally and in writing. Strong interpersonal and influencing skills. Ability to manage complex issues and distill information with proven negotiating skills

Responsibilities

• Independently support later stage products with minimal number of clinical trials or one indication on large, late-stage products.  Present compound safety data for later stage products with minimal number of clinical trials or a therapeutic indication of large, late-stage products within PPS and Clinical Teams or in support of an SDA
• Assist the safety data architect in coordination of deliverables and meetings to review data in aggregate with the PST Leads and PST TA physicians. Proactively utilize clinical experience and medical knowledge to support the review of potential safety concerns from clinical trial data. In partnership with the safety data architect support contribution of clinical trial data to regulatory response
• Ensure alignment, consistency, and data integrity for assigned safety activities.  Proactively promote best practice and knowledge sharing when communicating clinical trial data overviews. Apply advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug/device safety issues to assigned responsibilities as they impact on CTPS processes, procedures, and global reporting requirements
• Maintain expertise in CSA processes in order to serve as SME and complete study level reviews for Device products. Understand, implement and improve department SOPs as part of continuous improvement, including implementation of new regulatory requirements
• Support CTPS business operations, including but not limited to meeting and project planning, communication planning/alignment and ad hoc project support including project management. Identify areas of improvement in process/policy, develops recommendations/plan and align/maintain effective communication channels with key Clinical, Medical, Regulatory, Compliance, and Pharmacovigilance counterparts

Preferred Qualifications

RN or clinical pharmacy experience

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs