Tara Stewart

Lead safety operations for clinical trials, investigator-initiated studies, and post-marketing programs, including safety planning, database configuration, and closeout activities. Own aggregate safety assessments/reporting, SAE tracking reconciliation, non-conformance review, vendor oversight, and audit readiness through SOP/WI/template development.

Investigated and reviewed clinical study SAEs, including case assessment, SAE narrative revisions/approvals, and similar events analysis. Authored/reviewed regulatory and periodic safety reports, managed product safety governance, responded to health authority information requests, and supported CRO PV quality oversight and process improvements.

Oversaw pharmacovigilance operations and case management for safety reporting across investigational and commercial products. Managed PV vendors, developed PV policies/SOPs and performance metrics, reconciled safety reports and product complaints, and supported inspection readiness and trial team safety activities.

Conducted drug safety surveillance by reviewing site-reported AEs/SAEs, ensuring appropriate tracking, coding, and classification for reporting. Performed QC of individual case processing and subscriber reporting deliverables, supported AE validation workflow development, trained PV staff, and managed safety communications with clinical sites and investigators.

Performed clinical evidence review supporting Clinical Performance Summaries and post-market surveillance activities for medical devices. Coordinated sourcing and verification of clinical information and ensured documentation accuracy and alignment with internal and external evidence; supported staff training in quality systems and regulatory requirements.

Remediated medical device regulatory files by reviewing regulatory report deliverables and supervising MDR and vigilance report processing. Assessed reportability using decision trees across multiple regions, evaluated complaint remediation needs, ensured accuracy of complaint-handling data, and trained staff on relevant quality and regulatory requirements.

Supported post-market clinical surveillance by completing MDR/AE reporting and coordinating international regulatory issues within regulatory timeframes. Drafted MDR/MedWatch/Vigilance and other regulatory reports, coordinated core quality processes (documentation control, supplier controls, CAPA, complaints), and reviewed promotional materials and labeling for regulatory compliance.

Processed drug safety adverse event data from clinical trials, spontaneous, and literature sources, including follow-up with HCPs, investigators, and consumers. Drafted and submitted AE/SAE narratives to worldwide regulators, ensured MedDRA and WHO Drug coding accuracy, led SAE tracking and reconciliation, and supported PSUR data collection and consistency checks.

Coordinated injury prevention research projects, cooperative agreements, and contracts for OMB clearance submission. Provided technical assistance to project staff, led train-the-trainer sessions, reviewed RFPs, edited/submitted departmental web content, and maintained reporting databases.

Led the development, implementation, and evaluation of school health research projects and programs, including recruitment, mentorship, and team management across regions. Managed a $20 million departmental budget, led research monitoring and onsite compliance activities, and improved processes through standardization and adoption of new technologies.

Earned a Master of Public Health (MPH) at the Arnold School of Public Health.

Earned a Bachelor of Science in Biology with a minor in Chemistry.