Ariana Murillo

Pharmacist with extensive experience across Pharmacovigilance (PV), Safety Data Management, and Health Data Analytics. Proven expertise in safety database operations (ARGUS Safety), signal detection/management support, regulatory compliance under GVP/ICH guidelines, and cross-functional technical oversight. Holds advanced Master's degrees in Computational Biomedical Engineering and Biomedical Technologies Management, bringing strong analytical capabilities in data processing, biostatistics, and coding tools (Matlab, Python).

Track record of drafting technical documentation (SOPs, WPs, protocols), supporting system-level change management, and coordinating cross-functional teams to ensure safety database integrity and regulatory submission compliance. Fully fluent in Spanish and English.

Predoctoral Researcher at Institut de Recerca Sant Pau - Centre CERCA (Centre de Recerca de Catalunya) (2026-02 – Present)

• Documentation & Regulatory Submissions: Led end-to-end writing, technical review, and regulatory management of clinical protocols and study documentation, ensuring compliance with GCP and ICH standards.
• Safety Data Monitoring: Monitored safety data and clinical outcomes across trial pipelines, supporting robust medical evaluations and data consistency.

Digital Health Assistant at Almirall (2025-02 – 2026-02)

• Data & System Compliance: Managed data compliance and operational workflows across sub-studies, tracking device usage metrics and data integrity.
• Change Management & Documentation: Developed internal work instructions, presentation decks, and technical communication materials to align cross-departmental teams on study progress and data trends.

Assistant Clinical Project Manager at Clario (2024-03 – 2024-09)

• Project Lead & Workflow Optimization: Evaluated study protocols, Data Management Plans (DMPs), and operational workflows to optimize system execution and cross-functional quality standards.
• Issue Tracking & Change Coordination: Managed international cross-functional teams and vendor deliverables, tracking technical reviews, IT/system issues, and critical operational milestones.

Regulatory Affairs Assistant at The Blue Box Biomedical Solutions (2022-10 – 2023-06)

• Technical Writing & Standard Procedures: Authored and curated technical regulatory documentation, risk management strategy (ISO 14971/13485), and standard compliance files under EU frameworks.

Safety Data Management Specialist at Pfizer (2021-02 – 2022-09)

• Safety Database Administration & QC: Processed, coded, and validated ICSRs and SAEs in ARGUS Safety Database in compliance with GVP, ICH, and E2B standards. Maintained strict data consistency and integrity across post-marketing and clinical trial safety domains.
• Active Safety Follow-Up & Data Collection: Managed targeted follow-up procedures for SAEs and special population cases (e.g., pregnancy exposures). Issued, reviewed, and reconciled medical questionnaires to collect critical safety data, entering detailed real-time updates and follow-up documentation into ARGUS in line with GCP.
• Cross-Functional Alignment & Regulatory Compliance: Collaborated with global safety, medical, and IT teams on SAE follow-ups, database query resolution, and system-level data validation.
• Technical Writing & Narrative Generation: Authored detailed patient narratives, processed medical coding (MedDRA/WHO-Drug), and managed case documentation to ensure safety database readiness for global regulatory reporting.

Hospital Pharmacist at National Children's Hospital, Dr. Carlos Sáenz Herrera (2018-10 – 2021-02)

• Managed clinical pharmacy and pharmacovigilance operations in high-risk pediatric specialties (oncology, parenteral nutrition), assessing adverse drug reactions and ensuring drug safety compliance.

Clinical Pharmacist at Caja Costarricense del Seguro Social (2016-05 – 2018-10)

• Led pharmacotherapy optimization and patient counseling initiatives, supporting institutional pharmacovigilance programs, adverse event reporting, and medication safety evaluations across public health settings.

Pharmaceutical Sales Representative at Pierre Fabre Laboratory (2016-01 – 2016-04)

• Promoted pharmaceutical products across multiple specialties, building customer portfolios and strengthening stakeholder engagement.
• Delivered scientific training and presentations to healthcare professionals.

Retail Pharmacist at La California Pharmacy (2015-09 – 2015-12)

• Managed prescription dispensing, patient counseling, and daily pharmacy operations in compliance with regulations.

MSc in Computational Biomedical Engineering – Universitat Pompeu Fabra (2025)

MSc in Biomedical Technologies Management and Development – Universidad Carlos III (2023)

Pharmacy Degree in Pharmacy – Universidad de Iberoamérica (UNIBE) (2015)