Raejanna Ashley

Pharmacovigilance and Clinical Research professional with 12+ years of experience spanning drug safety operations, clinical trials, regulatory affairs, and data management. Proven expertise in end-to-end ICSR processing, MedDRA/WHO-DD coding, aggregate reporting (DSUR, PAER), and safety database management (Argus). Recognized for mentoring teams, ensuring regulatory compliance, and supporting signal detection and safety review activities.

Adept at working cross-functionally with CROs, sponsors, and regulatory bodies in fast-paced environments.

Drug Safety Associate I at Dynavax Technologies (2022-03 – Present)

• Process high-volume Individual Case Safety Reports (ICSRs) from clinical and post-marketing sources in compliance with global regulatory requirements and company SOPs
• Perform end-to-end case handling including triage, data entry, MedDRA/WHO-DD coding, narrative writing, and follow-up with reporters
• Conduct quality review of safety cases to ensure accuracy, completeness, and regulatory reportability
• Prepare and submit expedited and periodic safety reports (DSUR, PAER) to regulatory authorities and stakeholders
• Support signal detection activities by preparing safety data for Product Safety Review Committees
• Lead reconciliation activities across clinical trials, vendors, and internal systems to ensure data consistency
• Mentor and train team members, improving consistency and quality of case processing
• Generate compliance metrics and trend reports to support management decision-making
• Support audits and inspections by maintaining audit-ready documentation and contributing to CAPA activities
• Contribute to SOP and work instruction development to enhance operational efficiency

Pharmacovigilance Operations Coordinator II at IQVIA (2020-12 – 2022-03)

• Managed safety inbox and triage process, ensuring timely identification and processing of adverse event reports
• Processed ICSRs in accordance with SOPs and regulatory guidelines, including coding, narrative development, and case evaluation
• Evaluated case data for completeness, accuracy, and regulatory reporting requirements
• Coordinated with data management teams to reconcile safety and clinical databases
• Ensured timely submission of expedited and periodic safety reports
• Participated in audits and inspections, ensuring compliance with regulatory standards

Senior Data Specialist / Clinical Research Coordinator (Contract) at Pfizer via Aerotek (2020-07 – 2021-03)

• Managed data cleaning and query resolution processes for clinical studies
• Reviewed and interpreted data discrepancies, ensuring database accuracy and readiness for analysis
• Supported development of CRF completion guidelines and data entry conventions
• Contributed to validation testing and system implementation processes

Senior Clinical Research Coordinator at Children's Healthcare of Atlanta (2015-11 – 2019-08)

• Led clinical trial start-up and patient recruitment strategies in collaboration with sponsors and CROs
• Ensured compliance with GCP, ICH guidelines, and regulatory requirements
• Managed study documentation, TMF submissions, and audit preparation
• Developed SOPs and improved study start-up processes

Project Coordinator at Children's Healthcare of Atlanta (2015-04 – 2015-11)

• Supported project management activities and ensured clinical trial deliverables were met
• Monitored protocol adherence and identified process improvements

Regulatory Affairs Specialist at Children's Healthcare of Atlanta (2012-11 – 2015-04)

• Managed regulatory submissions and liaised with IRBs, sponsors, and investigators
• Prepared documentation for audits and ensured regulatory compliance

Clinical Trials Assistant at Children's Healthcare of Atlanta (2008-06 – 2012-11)

• Supported clinical trial operations including recruitment, screening, and study coordination

Bachelor of Science in Criminal Justice (Minor: Forensics) – American Public University (2019)

Diploma in Medical Administrative Specialist – Asher School of Business (2001)