Job Description

About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at abbvie. com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Purpose : 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. To create a culture of process improvement, employee development, performance measures, project prioritization, and to develop/implement successful solutions leading the CTPS team, translating the business vision into broad and actionable strategies. Responsibilities : This position is responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing and continuous improvement efforts. Supports Director of CTPS. Core Job Responsibilities include: • Manages assigned operational area(s)compound associated clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner meeting quality outputs within an inspection-ready environment. • Establish, monitor, evaluate, and communicate workload projections and metrics for operational area(s). • Supports department and divisional training programs, ongoing knowledge attainment, and development of staff by effectively identifying department and division needs and successfully presenting them to management. • Creates and sustains an environment that attracts, develops, and retains talented scientific professionals. Plans and conducts active talent management. • Assist management with strategic planning and department development.

Develop and participate in special projects for respective teams or CTPS initiatives. • Applies advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug safety issues to assigned responsibilities as they impact on CTPS processes, procedures, and global reporting requirements. • Partner with therapeutic area MDs/medical monitors to provide oversight of medical safety review at the compound study level, including ad-hoc safety reports, IRB/IEC safety issues, narratives, etc. • Provide oversight of narrative deliverables, issue management, document management systems, and centralized data review for assigned compound associated clinical studies. Effectively communicates/escalates relevant study and/or team-related information to appropriate clinical team members and/or management. • Understands, implements and improves department SOPs as part of continuous improvement, including implementation of new regulatory requirements. • Aligns and maintains effective communication channels with key clinical, medical, study team, including regulatory, compliance, and pharmacovigilance counterparts. Provides perspective, insight and benchmark information and approaches for business-related initiatives. • Manages 5 to 10 people. - Bachelor’s degree in a healthcare discipline (i. e. Life Science, Pharmacy, Nursing or healthcare profession, or biomedical disciplines). Graduate degree preferred. 10 years of experience in clinical research in the pharmaceutical industry. - Project management experience with cross-functional projects. Knowledge of the drug development process which includes clinical trial conduct, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.

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