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

This position supports the Clinical Trial Patient Safety (CTPS) 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. An effective communicator contributes to and creates a culture of process uniformity and quality, ensuring alignment, consistency, and integrity of safety data.
This position is responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts. Supports Associate Director of CTPS.      

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

•Provides oversight of compound topics or all CSA activities (i.e. coordinating compound/indication/program level standardization for studies and quality assurance activities).   Enables data driven insights to support the evaluation of the safety profile for development products via being a study lead and safety lead on studies within their assigned compound. May involve collaboration with and oversight of a vendor performing study safety data review activities to ensure quality deliverables
•Maintains expertise in Clinical Safety Analyst (CSA) study level processes to serve as subject matter expert.    Independently coaches and mentors designated team of safety staff. May have oversight of contractor staff.
•Leads study start activities and narrative deliverable activities in conjunction with study CSA lead to ensure standardization within the compound.  Proactively utilizes clinical experience and medical knowledge to support the review of potential safety concerns from clinical trial data.
•Demonstrates and promotes best practice and knowledge sharing when communicating clinical trial data overviews. Utilizes project management skills to ensure alignment, consistency, and data integrity for assigned safety activities.
•Develops and participates in special projects for respective teams or CTPS initiatives or on cross-functional initiatives.  Understands, implements, and ensures compliance with department guidelines and work instructions as part of continuous improvement, including implementation of new regulatory requirements. May participate in audit/inspection activities.
•Applies 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.
•Identifies areas of improvement in process/policy, develops recommendations/plan and maintains effective communication channels with key Clinical, Medical, Regulatory, Compliance, and Pharmacovigilance counterparts.

Qualifications

 

•Bachelor’s degree preferred with related health science background is required. RN or clinical pharmacy experience strongly preferred. A minimum 6 years clinical experience to include at least 3 years of clinical practice experience and 2 years drug safety experience with clinical trial life cycle management – Pre-clinical to Phase III through launch to market.
•Demonstrates excellent interpersonal, leadership, communication, and development skills. Able to give and receive constructive feedback. Ability to identify, prioritize and assign tasks to contractors and lead others. Demonstrates 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.
•Excels in computer skills (Windows, Word, Excel, PowerPoint, MS Teams). Proven ability to navigate in multiple complex safety database programs (e.g., oracle/clinical, EDC, laboratory databases). Accurate and medically sound presentation of case data, orally and in writing. Strong interpersonal and influencing skills. Monitor problems through resolution.  Develop and share lessons learned with team.
•Analyze and interpret adverse event data as a component of clinical surveillance activity.  Consistently exercise good judgment within policies and regulations.  Ability to critically evaluate medical data. Demonstrates ability to manage complex issues and distill information with proven negotiating skills.  Expertise in industry regulations, processes, and clinical trial safety. In depth understanding of product safety profile including labeling, literature, clinical and regulatory issues.
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Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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