TARA THORSEN
Bernardsville,NJ
Summary
Highly organized and self-motivated professional experienced in project management, metric development and process improvement. Skilled in developing and implementing strategies to increase efficiency and performance. Passionate about driving business growth and creating positive work environment.
Overview
19
19
years of professional experience
Work History
Associate Director, Quality
Pfizer
08.2010 - 05.2024
- Provide strategic Quality oversight for the Signal Detection, Evaluation, and Risk Management business area
- Leads data production of compliance and performance metrics, quality management/trending of relevant root cause analysis, and corrective and preventative actions
- Point of contact for inspection/audit requests and results for signal detection, evaluation, and risk management areas
- Key role in Quality governance meetings with senior Pfizer leaders, to report on KPIs for Safety, Risk Management and Aggregate Reporting business areas
- Co-author Signal Detection, Evaluation, and Risk Management Quality Plan
- Author/owner of work instructions on relevant metric generation and quality oversight processes, such as Special Safety Concerns metrics, Clinical Data reporting metrics, and Product Surveillance metrics.
Manager
Pfizer
08.2008 - 08.2010
- Serve as subject matter expert for Worldwide Safety & Regulatory business lines on metrics, data analysis, knowledge sharing, or specific work processes, providing advice and guidance
- Manage global compliance monitoring through compilation, gap analysis, and resolution implementation
- Review business processes/procedures to support continuous process improvement and organizational evolution
- Develops, with key stakeholders, strategies for creation and collection of metrics for relevant processes/products.
Senior Associate
Pfizer
03.2005 - 08.2008
- Generation and analytics of integrated compliance and performance data relative to areas of delay, trending of aggregate data, root cause analysis, and corrective action planning
- Assess timeliness of adverse event reports processed by SRM in accordance with applicable guidelines
- Contribute to the identification of process enhancements and continuous improvement.
Education
Master's - Clinical Research Organization & Management
Drexel University College of Medocine
Philadelphia, PA05.2008
Bachelor's - Nutritional Sciences
Rutgers University, Cook College
New Brunswick, NJ12.1999
Skills
- Analytical Skills - 10 years
- Project Management - 10 years
- Key Performance Indicators - 10 years
- Quality System - 10 years
Timeline
Associate Director, Quality
Pfizer
08.2010 - 05.2024
Manager
Pfizer
08.2008 - 08.2010
Senior Associate
Pfizer
03.2005 - 08.2008
Master's - Clinical Research Organization & Management
Drexel University College of Medocine
Bachelor's - Nutritional Sciences
Rutgers University, Cook College