Silvia Fernández Rubio

Experience

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  Centro de Investigación del Cáncer (IBMCC-FICUS)

  Jul 2016 - Jul 2017

  Research project

  "Efectos de la deficiencia de Snai2 en cáncer de mama de estirpe luminal ErBb2+"Trabajo de investigación realizado con el Dr. Jesús Pérez Losada

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  Hospital Universitario De Burgos

  Feb 2017 - Jul 2017

  Hospital Pharmacist internship

  - Preparation of compounded medications- Assistance in the preparation of oncological drugs- Validation of treatments for hospitalized patients- Preparation of unit dose medications- Management of clinical trials- Outpatient dispensing of antiretroviral treatments, biological drugs, etc., and follow-up to validate treatment adherence- Participation in the development and review of the hospital's pharmacotherapeutic guide- Attendance at team meetings and hospital training sessions Show less

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  Farmacia Víctor Manuel Moldes Fernández

  Aug 2017 - May 2018

  Pharmacist

  - Dispensing drug with a strong focus on personalized pharmaceutical care- Monitoring of patients' treatments to improve adherence and compliance- Detecting potential adverse reactions and notification (pharmacovigilance)- Identifying potential drug interactions- Drafting standard operating procedures (SOPs)- Controlling and managing stock and expired products- Development of health promotion activities- Handling and managing orders

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  Farmacia E Cases Nabau

  Apr 2019 - Aug 2019

  Pharmacist

  - Preparation and dispensing of compounded medications- Dispensing drugs and personalized pharmaceutical care- Developing training sessions for pharmacy technicians- Pharmacovigilance tasks- Drafting standard operating procedures (SOPs)- Controlling and managing stock and expired products- Handling and managing orders

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  Farmacia Jorge Gómez Sancho

  Aug 2019 - Sept 2020

  Pharmacist

  - Dispensación de medicamentos con un enfoque sólido en la atención farmacéutica personalizada.- Seguimiento de los tratamientos de los pacientes para mejorar la adherencia y el cumplimiento del tratamiento.- Detección de posibles reacciones adversas y notificación de las mismas (farmacovigilancia).- Identificación de posibles interacciones medicamentosas.- Redacción de procedimientos.- Control y gestión de stock y productos caducados.- Desarrollo de actividades de promoción de la salud.- Gestión de pedidos. Show less

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  Grifols

  Jan 2021 - now

  - Vigilance of in vitro diagnostic medical devices (IVD) (recalls, FSCA, FSN).- Post-market surveillance activities for in vitro diagnostic medical devices (PMSR, PSUR, RMP, annual reports).- Management of customer complaints, non-conformities, CAPAs, Change Controls and other quality notifications. - Reportability assessment of complaints or non-conformities to competent authorities (BDPR, MDR, FSCA, MIR).- SAP knowledge.- Servicemax (Salesforce) knowledge.- Risk analysis of complaints and incidents reported. Show less - Vigilance of in vitro diagnostic medical devices (IVD) (recalls, FSCA, FSN).- Post-market surveillance activities for in vitro diagnostic medical devices (PMSR, PSUR, RMP, annual reports).- Management of customer complaints, non-conformities, CAPAs, Change Controls and other quality notifications. - Reportability assessment of complaints or non-conformities to competent authorities (BDPR, MDR, FSCA, MIR).- SAP knowledge.- Servicemax (Salesforce) knowledge.- Risk analysis of complaints and incidents reported.- Risk analysis with JAMA software.- Projects related to the improvement of the company's quality system, ensuring compliance with applicable GMP (ISO 13485, 21CFR820, 21CFR600, IVDR).- Participation in internal and external audits. Show less - Drafting and review of protocols (SOPs)- Extraction and processing of data to obtain monthly and quarterly KPIs (quality metrics)- Complaints management (initial reports, investigation reports, customer response letters and final reports, reportability assessment, risk assessment, CAPAs implementation, etc.)- Audit quality questionnaires- Support in the management of CAPAs, complaints and non-conformities (OOS)- Supplier quality agreements- Product risk analysis- SAP system knowledge- Medical device vigilance system- Management of cross-departmental meetings Show less

  • Complaints and Post-market Surveillance Specialist

    Feb 2024 - now

  • Quality compliance Specialist

    Jan 2022 - Mar 2025

  • Quality Assurance trainee

    Jan 2021 - Jan 2022