Giselle Moody

Accomplished healthcare leader with over 28 years of experience in quality improvement, patient safety, and risk management. Proven expertise in leading enterprise-wide change initiatives, coaching executive sponsors, and integrating change management strategies into complex healthcare systems. Skilled in stakeholder engagement, resistance management, and fostering adoption of new processes, technologies, and organizational structures. Dedicated to creating safe, efficient, and patient-centered care environments.

Professional safety specialist prepared to elevate workplace safety standards. Skilled in risk assessment, hazard prevention, and regulatory compliance. Strong focus on team collaboration and achieving results, adaptable to changing needs. Known for reliability and effective communication in high-stress environments.

• Reviewed and triaged global patient safety complaints, ensuring timely escalation and resolution per FDA and international regulatory guidelines.
• Collaborated with cross-functional teams (quality, regulatory, medical affairs) to investigate patient-reported adverse events and product complaints, leading to a 25% reduction in complaint recurrence.
• Conducted root cause analysis (RCA) on serious safety events, documenting findings in global tracking systems and initiating CAPAs (Corrective and Preventive Actions).

• Identified trends in documentation and reporting errors, launching a quality improvement initiative that reduced critical errors by 40% within 6 months.
• Led weekly cross-functional huddles to review safety issues and documentation gaps, enhancing real-time accountability and team alignment.

• Conducted routine literature surveillance to identify emerging safety signals and published evidence related to product performance and patient risk.
• Summarized relevant peer-reviewed safety data for inclusion in internal risk assessments and global product dossiers.

• Supported internal audits and FDA readiness by maintaining up-to-date complaint files and safety documentation for all product families under your review.
• Authored and maintained SOPs related to safety documentation, complaint handling, and literature surveillance in alignment with global regulatory standards.

• Trained new team members and global affiliates on adverse event identification, documentation standards, and complaint escalation protocols.
• Partnered with global medical safety and clinical affairs teams to align post-market surveillance data with real-world evidence trends.

• Generated monthly safety and complaint trend reports presented to leadership, contributing to improved decision-making and compliance tracking.
• Monitored KPIs for complaint turnaround time, investigation completeness, and closure rates, consistently meeting or exceeding internal benchmarks.

• Six Sigma Green Belt – 2016
• TeamSTEPPS Instructor – 2012
• Clinical Safety & Effectiveness Program – 2017
• Healthcare Accreditation Certified Professional (HACP) – 2017
• Deployed Military Treatment Center Patient Safety Program – 2019
• Allergy & Immunotherapy Course – 2008
• Principles of Instruction – 2007