Delana Norfleet
Clarksville
Summary
Experienced Safety and Pharmacovigilance (PV) professional with 8 years in the Contract Research Organization (CRO) industry. As a Senior Safety and PV Specialist, expertise spans clinical trials across Phase I, II, and III studies, ensuring regulatory compliance and delivering high-quality safety data. Background in Health Information Management enhances understanding of medical data integrity and supports contributions to the Biopharmaceutical Acceleration Model, advancing drug development.
Overview
15
15
years of professional experience
Work History
Sr Safety & PV Specialist
Syneos Health
Morrisville
07.2022 - 06.2026
- Effectively managed project risks and issues related to safety and pharmacovigilance.
- Monitored financial performance metrics, project budgets, and quality parameters.
- Assisted in developing comprehensive project plans, including safety management strategies.
- Coordinated workflows to ensure projects met deadlines consistently.
- Distributed and monitored team workloads to maximize resource efficiency.
- Promptly escalated deliverable, financial, and quality issues to appropriate leads.
- Participated in internal project reviews and facilitated safety data reconciliation with data management staff.
- Served as subject matter expert in pharmacovigilance, providing mentorship and resolving queries.
Safety Lead
Sarah Cannon
03.2020 - 07.2022
- Maintained project plan and managed monthly revenue recognition and forecasting activities.
- Executed invoicing in accordance with contract terms, ensuring accuracy and compliance.
- Provided project information to financial analysts for enhanced decision-making.
- Developed and reviewed safety sections of various regulatory documents.
- Collaborated with global safety teams on pharmacovigilance and clinical activities.
- Cultivated relationships with clients across US, EU/UK, and APAC regions.
- Oversaw financial management as safety project leader for standalone service projects.
- Mentored junior team members to improve skills related to pharmacovigilance activities.
Safety Coordinator
Sarah Cannon
07.2015 - 03.2020
- Acquired new datasets from business clients and vendor partners for thorough analysis.
- Integrated datasets into standardized architecture, enhancing accessibility for users.
- Analyzed data to uncover actionable insights and identify savings opportunities.
- Executed data requests through precise queries to fulfill stakeholder needs.
- Distributed incoming SAE reports and sponsor query forms to relevant stakeholders.
- Posted SAE reports and documents in safety department's electronic repository following naming conventions.
- Streamlined communication processes, ensuring timely sharing of information with stakeholders.
Safety Specialist
Sarah Cannon
11.2014 - 07.2015
- Executed data entry for incoming serious adverse event reports into Argus database.
- Tracked case query resolutions with sites to ensure timely closure.
- Developed and maintained departmental shared website for templates, forms, reference documents, and contact information.
- Conducted regular quality checks on assigned studies, ensuring proper maintenance and filing of safety documents.
Document Processor
Davita
10.2011 - 11.2011
- Identified and implemented indexing processes, improving overall document accuracy.
- Executed chart retrieval and filing processes to streamline unit workload.
- Provided training support and mentorship on clinical documentation to enhance staff proficiency.
- Participated in ICD-10 coding training and contributed to transition plans for special projects.
Education
Masters - Master Science in Healthcare
Trevecca Nazarene University
Nashville, TN01-2019
Bachelor - Health Information Management
Tennessee State University
Nashville, TN01-2011
Skills
- Pharmacovigilance
- Adverse event reporting
- SAE reconciliation
- Clinical documentation review
- Quality assurance
- Data analysis
- JReview and Power BI
- Rave EDC
- Report generation and metrics
- WHO drug database management
- Client management
- Mentoring
- Time management
- Communication
Company
Syneos Health
Personal Information
Title: Sr Safety & PV Specialist, Safety & Pharmacovigilance
Therapeutic Experience
- Oncology, Blood & blood forming malignancies, Non-Hodgkin lymphoma (NHL)
- Oncology, Miscellaneous cancer, Bone metastases
- Oncology, Solid tumors, Bladder cancer
- Oncology, Solid tumors, Breast cancer
- Oncology, Solid tumors, Colorectal cancer
- Oncology, Solid tumors, Glioblastoma multiforme
- Oncology, Solid tumors, Head & neck cancers
- Oncology, Solid tumors, Pancreatic cancer
- Oncology, Solid tumors, Renal cell carcinoma (RCC)
- Oncology, Solid tumors, Soft tissue sarcoma
- Oncology, Solid tumors, Solid tumor indications
Last Modified Date
07/08/25
Timeline
Sr Safety & PV Specialist
Syneos Health
07.2022 - 06.2026
Safety Lead
Sarah Cannon
03.2020 - 07.2022
Safety Coordinator
Sarah Cannon
07.2015 - 03.2020
Safety Specialist
Sarah Cannon
11.2014 - 07.2015
Document Processor
Davita
10.2011 - 11.2011
Masters - Master Science in Healthcare
Trevecca Nazarene University
Bachelor - Health Information Management
Tennessee State University