Hanasia Booker
Summary
Clinical data and pharmacovigilance professional dedicated to managing clinical safety data with a focus on accuracy and regulatory compliance. Proven ability to enhance patient safety through meticulous data validation, collaboration with cross-functional teams, and support for FDA submissions in a high-stakes environment.
Overview
5
5
years of professional experience
Work History
Data Safety Management Specialist
Pfizer - Contract
03.2026 - Current
- Manage clinical safety data within the Argus Safety Database, ensuring accuracy, completeness, data integrity, and regulatory compliance.
- Support FDA submissions, licensed partner notifications, and other regulatory reporting requirements related to clinical safety data.
- Conduct detailed clinical data review, validation, and reconciliation activities to support high-quality clinical databases.
- Collaborated with Clinical Operations, Pharmacovigilance, Regulatory Affairs, and cross-functional teams to ensure timely and accurate clinical data collection and reporting.
- Maintained audit-ready documentation and contributed to process improvement initiatives to enhance compliance within a regulated pharmaceutical environment.
- Analyzed operational data to identify trends and recommend process improvements.
Drug Safety Specialist
Synecos Health
10.2023 - 02.2026
- Processed and reviewed adverse event reports, ensuring data accuracy and completeness to support patient safety.
- Entered and maintained safety data within validated clinical databases to facilitate effective case management.
- Collaborated with sponsors and internal teams to ensure timely case processing and regulatory compliance.
- Maintained compliance with FDA regulations, ICH guidelines, and pharmacovigilance procedures to uphold regulatory standards.
- Supported inspection readiness through accurate documentation and adherence to quality standards.
Patient Support Specialist
ConnectiveRx
Whippany, NJ
12.2021 - 10.2023
- Maintained confidential patient records while ensuring compliance with HIPAA and internal procedures.
- Assisted with data entry, record maintenance, and documentation review, achieving compliance with productivity and quality metrics.
- Investigated documentation discrepancies and implemented corrective actions to ensure accurate patient records.
- Collaborated with cross-functional teams to streamline workflows and enhance data accuracy.
Education
Bachelor of Science - Health Administration
Rutgers, The State University of New Jersey
New Brunswick, NJ08-2024
Skills
- Technical:
- Adverse event reporting
- Regulatory:
- SQL
- Quality:
- Risk compliance auditing
- General:
- Process improvement management
- Communication
- Microsoft Excel
- Case management
Timeline
Data Safety Management Specialist
Pfizer - Contract
03.2026 - Current
Drug Safety Specialist
Synecos Health
10.2023 - 02.2026
Patient Support Specialist
ConnectiveRx
12.2021 - 10.2023
Bachelor of Science - Health Administration
Rutgers, The State University of New Jersey