Viviane Santos

Ensured compliance with HSE, HIQA and regulatory standards, developed standardized safety protocols and documentation workflows that reduced clinical deviations and improved audit readiness. Escalated clinical events and partnered with clinical teams to strengthen patient-safety reporting.

Managed GDP-compliant inventory and supply chain traceability for high-cost medicines, prepared regulatory documentation for inspections, and implemented expiry and batch-tracking protocols to reduce expired stock and compliance deviations.

Implemented barcode tracking systems to increase dispensing accuracy and batch traceability, improved pharmacovigilance workflows for nursing home residents, and optimized OTC inventory to reduce waste and support inspection readiness.

Monitored expiry dates and maintained accurate stock records to ensure GDP and dispensary compliance, implemented inventory tracking routines that reduced shortages and minimized expired products while supporting patient counseling.

Supported health authority inspections with 100% compliance, managed emergency regulatory authorizations (including COVID-19 medicines), and maintained SOPs and CAPA processes to sustain operations under high pressure.

Led ONA Level 3 accreditation and aligned QMS with ISO 9001, GMP and GDP standards achieving zero major findings; reviewed 30+ SOPs, managed CAPAs and reduced recurring errors by 35% while improving pharmacovigilance and batch traceability.

Ensured GMP compliance and traceability for medical devices and pharmaceuticals, led cold-chain monitoring and aseptic oncology compounding protocols, and implemented 5S and barcode verification to reduce medication errors by 15%.

Pursuing a Master's in Medical Technology - Regulatory Affairs (NFQ Level 9) with focus on EU MDR, IVDR, ISO 13485, clinical evaluation, FDA 21 CFR 820, and ISO 14971 risk management.

Completed a postgraduate program in Oncology Hospital Pharmacy focused on clinical oncology pharmacy practices and hospital pharmacy workflows.

Completed a postgraduate program in Hospital Pharmacy Management covering pharmacy operations, management, and regulatory compliance in hospital settings.

Earned a Bachelor of Pharmacy (NFQ equivalent Level 8) covering pharmaceutical sciences, clinical pharmacy, and regulatory compliance.