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
08.2023 - 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
04.2022 - 08.2023
- 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
02.2021 - 04.2022
- 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
01.2013 - 11.2019
- 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
05.2008 - 12.2012
- 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 (eg, 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
08.2023 - Current
Senior Manager of Global Product Safety
Chinook Therapeutics
04.2022 - 08.2023
Manager of Alliance Partner Compliance & Quality
Johnson and Johnson Pharmaceuticals
02.2021 - 04.2022
Manager of Drug Safety Surveillance
AbbVie
01.2013 - 11.2019
Senior Medical Safety Analyst
Abbott Laboratories
05.2008 - 12.2012
Master of Science - Management & Leadership
Purdue University
Bachelor of Science - Registered Nurse
Kaplan University
Similar Profiles
Tracy WoodsTracy Woods
Senior Manager/Associate Director at Chinook Therapeutics, A Novartis CompanySenior Manager/Associate Director at Chinook Therapeutics, A Novartis Company
Sean KingSean King
Clinical Systems Administrator at Chinook TherapeuticsClinical Systems Administrator at Chinook Therapeutics
Lilli MonieLilli Monie
Farm and General Assistant at Chinook Pastoral CompanyFarm and General Assistant at Chinook Pastoral Company