Tracy Woods
Alvin,Texas
Summary
Positive leader who is versatile, and a deep problem solver who has challenged by taking on progressive levels of responsibility successfully through developing and implementing strategies to increase performance and efficiency. Developed an ardent desire to further knowledge in the pharmaceutical industry to make a greater impact on patients participating in clinical trials. Focusing on patient advocacy, quality, compliance and risk management and diligently working as a part of the global pharmacovigilance team to bring safe and effective drugs to the market.
Overview
11
11
years of professional experience
Work History
Senior Manager/Associate Director
Chinook Therapeutics, A Novartis Company
2023.08 - Current
- Provided strong leadership to enhance team productivity and morale with 4 contracted vendors.
- Implemented and developed operational standards, policies and procedures.
- Achieved operational excellence by streamlining processes and implementing best practices.
- Demonstrated exceptional adaptability in navigating complex situations or rapidly changing environments with ease.
- Balanced competing priorities efficiently while maintaining focus on critical tasks requiring immediate attention.
Senior Manager
Chinook Therapeutics
2022.04 - 2023.08
- Established strong relationships with 4 major vendors, ensuring long-term partnerships and repeat business.
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Implemented and developed operational standards, policies and procedures.
Manager, Alliance Partner Compliance
Johnson & Johnson
2021.02 - 2022.04
- Accomplished multiple tasks within established timeframes.
- Onboarded (5) new employees with training and new hire documentation.
- Cross-trained existing employees to maximize team agility and performance.
Manager, Drug Safety Surveillance
AbbVie
2013.01 - 2019.11
- Managed and motivated employees 12 to be productive and engaged in work.
- Accomplished multiple tasks within established timeframes.
Education
Master of Science - Management & Leadership
Purdue University
Davenport, IA04.2020
Bachelor of Science - Nursing
Kaplan University
Davenport, IA06.2013
Skills
- ICSR Medical Review, Expedited/Adverse Event reporting
- Authoring Clinical SOPs/IB/SMP/ICF/RMPs/RSI/Label
- Pharmacovigilance (Scientist-Specialist)
- Regulatory Compliance (FDA, EMA)
- Safety Monitoring & Signal Detection
- MedDRA and WHODrug Coding
- Surveillance Scientific Literature
- Aggregate Safety Reporting (e.g., DSURs/PADERs/PBRERs)
- SAE Reconciliation
- Cross-functional (Matrixed) Collaboration
- Inspection Readiness Quality, Auditing & CAPA/Deviations
- Data Mining & Review of Outputs, Statistical Data Analysis
- Operations Management
- Strategic Planning
Leadership Experience
Successfully lead Vendor Quality Compliance Investigators to ensure greater than 95% compliance and reporting timeliness of partner investigations for compliance outcomes to support organizational excellence.
Communication Skills
Implemented a new department process to manage Work in Progress – Workflow to prioritize case submissions by due date allowing integrating self-pull system. Empowering individuality in a team environment while promoting ownership of the work.
Roles And Responsibilities
Overseeing and managing daily outsourced vendor operations for adverse event reporting/submissions, ensuring compliance with KPI metrics per GXP guidelines. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing. Monitors the safety mailbox for adverse event management. Provides medical review of Individual Case Safety Reports (ICSRs). Accountable for analyzing compliance trends/tracking expected terms for safety signals that impact the investigational product safety profile. Ensures PV processes are well documented to support regulatory and PV activities. Oversight of quality management vendors in accordance with Good Clinical Practice (GCP) guidelines. Proven ability to develop rigorous risk assessments, and implement robust risk mitigation strategies for the documentation and managing of CAPAs in the Quality Management System and Trackwise. Examines risks and suggests preventative action. Participates in the development of quality improvement initiatives. Troubleshoots and manages multiple projects simultaneously. Review standard design of tables, figures, and listings for safety data from clinical studies. Reviews and approves safety sections of all clinical study reports (CSRs) (including interim as well as final reports). Participates in the development of safety-related data collection forms for clinical studies. Prepares presentations of the Global Safety Team's recommendations on safety issues to the cross-functional teams. Ensures the Trial Master File is up to date with relevant safety documents per Zone 7 Safety. Support internal and Vendor PV audits. Panel member to support the hiring of new employees and a mentor.
Personal Information
Title: Senior Manager/Associate Director
References
Available upon request.
Timeline
Senior Manager/Associate Director
Chinook Therapeutics, A Novartis Company
2023.08 - Current
Senior Manager
Chinook Therapeutics
2022.04 - 2023.08
Manager, Alliance Partner Compliance
Johnson & Johnson
2021.02 - 2022.04
Manager, Drug Safety Surveillance
AbbVie
2013.01 - 2019.11
Master of Science - Management & Leadership
Purdue University
Bachelor of Science - Nursing
Kaplan University
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