Tracy Woods
Alvin,Texas
Summary
Forward-thinking Senior Manager with extensive experience as a Registered Nurse, and in Pharmacovigilance, Compliance and Risk Management. Proven track record in enhancing drug safety and operational excellence at AbbVie, and showcasing expertise of end-to-end process by implementing a new departmental process to manage Work in Progress – Workflow for prioritization of case submissions by due date allowing an integrated self-pull system. Empowering individuality in a team environment while promoting ownership of the work and elevating capabilities. Excelled at Johnson & Johnson leading (15) Vendor - Quality Compliance Investigators to ensure greater than 98% compliance and reporting timeliness of partner investigations for compliance outcomes to support organizational excellence with a passion for mentoring teams. Established/overseen and built strong rapports with (5) major vendors at Chinook Therapeutics, ensuring long-term partnerships and repeat business through fostering positive and collaborative communication.
Overview
16
16
years of professional experience
Work History
Senior Manager of Global Product Safety
Chinook Therapeutics, a Novartis Company
Seattle , WA
2023.08 - Current
- Provides strong leadership to Vendor/CRO teams enhance team productivity and morale with (4) contracted vendors dually optimizing resource allocation and reducing costs.
- Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing.
- Monitors global safety mailbox for adverse event and medical device management. Provides medical review of Individual Case Safety Reports (ICSRs) for expectedness and relatedness.
- Authors Safety Management Plans (SMPs) and collaboratively participated in drafting of Standard Operating Procedures (SOPs), Investigator Brochures (IB), Reference Safety Information (RSI) Protocol/Amendment review, Aggregate Safety Reporting (e.g., DSURs/PADERs/PBRERs), Risk Management Plans (RMPs)
- Ensures Vendor/CRO team compliance with KPI metrics per GXP/GCP guidelines.
- Participated in FDA's Bioresearch Monitoring, (BIMO) inspection for NDA approval of product under regulatory review.
- Addresses site/investigator related GPS queries.
- Supports Data Management and Medical Monitor by performing weekly and monthly clinical review of MedDRA and WHODrug coding and data listings from statistical output reports i.e. Electronic data capture (EDC)/Rave and creating queries.
- Balances competing priorities, GPS subject matter expert (SME) efficiently while maintaining focus on critical tasks requiring immediate attention in ALIGN, AFFINITY and ASSIST Clinical Studies.
- Demonstrates exceptional adaptability in navigating complex situations with serious adverse event reporting in rapidly changing environments with ease.
- Prepares presentations of Global Safety Team's recommendations on safety issues to cross-functional teams.
- Performs scientific Literature searches for surveillance of any safety issues.
- Ensures Trial Master File (TMF) is up to date with relevant safety documents per Zone 7 Safety section.
- Panel member to support hiring of new employees and strong lead mentor and trainer.
Senior Manager of Global Product Safety
Chinook Therapeutics
Seattle , WA
2022.04 - 2023.08
- Improved (4) Vendor/CROs team performance by providing comprehensive training on data collection forms, triage notification emails, draft narratives, and other study specific processes while fostering collaborative work environment.
- Ensures (4) Vendor/CRO team compliance with KPI metrics per GXP/GCP guidelines.
- Participated/addressed site/investigator related GPS queries from (3) clinical studies.
- Participates in development of quality improvement initiatives.
- Transcribes safety team meeting minutes and distributes them to team for reference.
- Escalates observed safety issues to leadership with proposed plan of action.
- Swift ability to influence in proactive and positive manner.
- Proficient in multitasking and working in fast-paced environment.
Manager of Alliance Partner Compliance & Quality
Johnson and Johnson Pharmaceuticals
Horsham , PA
2021.02 - 2022.04
- Oversight of quality investigations of Individual Case Safety Reports (ICSRs) submitted late to Health Authorities by Janssen and/or Consumer due to inbound delays from business partners.
- Prioritized/adapt to resolve complex issues to understand “big picture” and its impact to determine when escalation to senior management is appropriate.
- Educated and informed business partners of corrective/preventative actions and effectiveness measures for late ICSR and corrective action preventative action (CAPA).
- Onboarded (10) new employees with compliance training and new hire documentation of completion.
- Cross-trained existing employees to maximize team agility and performance.
- Routinely assessed resource demand and allocation across and within projects and adjusts as appropriate with quality escalation spikes.
- Determine best resource allocation of individuals based on their skills and career development.
- Raise resource issues to Center of Excellence Head and offer solutions.
- Served as Alliance Partner Manger SME for (3) or more projects.
Manager of Drug Safety Surveillance
AbbVie
North Chicago , IL
2013.01 - 2019.11
- Managed/trained, and motivated employees 12 to be productive and engaged in work in collaborative team environment
- Forecasted Work in Process (WIP) and staffing demands to drive deliverables for high volume case submission timelines.
- Expert understanding of International Conference of Harmonization (ICH)/FDA/European Union (EU) regulations and guidelines affecting drug safety reporting.
- Provided robust insights for streamlined process improvement initiatives for work efficiency gains via Case Processing Through-Put Monitor narrative report.
- Avid leader/representative of pharmacovigilance and cross-functional subject matter expert (SME).
- Accomplished multiple tasks within established timeframes.
Senior Medical Safety Analyst
Abbott Laboratories
North Chicago , IL
2008.05 - 2012.12
- Expertly case intake and triaged adverse event information from investigator sites, including Oncology, Immunology, Diabetes, Renal, Women and Men’s Health, Neurology, and Antiviral studies.
- Collects and analyzes, and reviews safety-related data from clinical trials with focus on serious (Clinical Phase I-IV) and non-serious (post-marketed-commercial) adverse events.
- Leveraged data analysis skills to track key safety case metrics.
- Write pre-clinical narratives for critical animal report cases.
- Preceptor and mentor (15) new hire/vendor training in all areas of work assignments and AbbVie practices and policies.
Education
Master of Science - Management & Leadership
Purdue University
West Lafayette, IN04.2020
Bachelor of Science - Registered Nurse
Kaplan University
Davenport, IA06.2012
Skills
- Inspection Readiness Quality, Auditing & CAPA/Deviations
- Accountable for reporting Key Metrics/Performance Indicators (KPIs)
- ICSR Narrative/Medical Review, Expedited/Adverse Event reporting
- Authoring Clinical SOPs/IB/SMP/ICF/RMPs/RSI/Label, Protocol/Amendment review
- MedDRA and WHODrug Coding RAVE, ARGUS, AEGIS, TrackWise - Quality Management System (QMS)
- Aggregate Safety Reporting (e.g., DSURs/PADERs/PBRERs)
- Surveillance Scientific Literature
- Review of Outputs, Basic Statistical Data Analysis
- SAE Reconciliation
- Cross-functional (Matrixed) Collaboration
- Diversity and Inclusion Initiatives
- Staff mentoring, training and development
Timeline
Senior Manager of Global Product Safety
Chinook Therapeutics, a Novartis Company
2023.08 - Current
Senior Manager of Global Product Safety
Chinook Therapeutics
2022.04 - 2023.08
Manager of Alliance Partner Compliance & Quality
Johnson and Johnson Pharmaceuticals
2021.02 - 2022.04
Manager of Drug Safety Surveillance
AbbVie
2013.01 - 2019.11
Senior Medical Safety Analyst
Abbott Laboratories
2008.05 - 2012.12
Master of Science - Management & Leadership
Purdue University
Bachelor of Science - Registered Nurse
Kaplan University
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