Associate Director, Clinical Trial Patient Safety

AbbVie

Associate Director role overseeing clinical trial patient safety data review and surveillance operations at a pharmaceutical company. Manages cross-functional teams, ensures regulatory compliance, and implements process improvements within the CTPS organization.

Responsibilities

Oversee worldwide surveillance of clinical trial safety data with focus on compliance and quality
Manage 5-10 direct reports and establish workload metrics for assigned operational areas
Partner with medical monitors and therapeutic area physicians on safety review oversight
Develop and communicate training programs, staff development, and talent management initiatives
Ensure adherence to ICH, FDA, EMA regulations and implement departmental process improvements

Requirements

Bachelor's degree in life science, pharmacy, nursing, or related healthcare discipline
10 years clinical research experience in pharmaceutical industry
Project management experience with cross-functional initiatives
Knowledge of drug development, clinical trial conduct, and regulatory requirements
Background in clinical operations, study management, or drug safety operations
Leadership and communication skills with ability to manage conflict and teams
Understanding of drug safety evaluation tools, standards, and approaches

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Vacancy posted 11 days ago

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