Luis Luque Email & Phone Number

Madrid, Community Of Madrid, Spain

Collaborated with the BI team monitoring, reviewing, adapting and approving local and global Market Researches conducted by outsourced vendors, according to local legislation. Effectively performed and documented the reconciliation of MRs. Participated in the integration of both local and global MRs platforms, reviewed status updates, and correctly documented according to regulations, ensuring readiness for inspections.Conducted quality control of ICSRs management process performed by… Show more Collaborated with the BI team monitoring, reviewing, adapting and approving local and global Market Researches conducted by outsourced vendors, according to local legislation. Effectively performed and documented the reconciliation of MRs. Participated in the integration of both local and global MRs platforms, reviewed status updates, and correctly documented according to regulations, ensuring readiness for inspections.Conducted quality control of ICSRs management process performed by vendors and accurately documented the results.Registered in the AEMPS as alternate contact person responsible for local PV and managed queries in a timely manner. Implemented and developed a local aRMMS (patient card) according to local regulations and quality-regulatory standards, including dissemination plan through medical societies.Collaborated as a member of the GxP group to monitor and establish quality processes. Issued investigations, CAPAs and deviations management. Local SOPs reviewed and updates, change controls and risk analysis related to the QMS in the GvP area. Participated in the migration from local drive to cloud server, ensuring the data integrity and quality standards. Supervised, tested, and provided feedback of Argus RPA to perform FU by email accurately and on time. Participated in onboarding sessions to provide PV training to new joiners and any employee working on behalf of the MC. Monitored vendor´s compliance with the annual PV training.Tested and ensured the annual business continuity plan and correctly documented its effectiveness. Show less

Madrid, Community Of Madrid, Spain

Collaborated in the maintenance of a PV system that ensures the registration of all safety information and the design, implementation, management, and control of a risk-benefit safety strategy that meets the requirements established by GPV and the Spanish Agency of Medicine.ICSR management: initial data collection and follow-up in accordance with the company's internal procedures. Assisted in compliance and QC activities, including the timely resolution and documentation of… Show more Collaborated in the maintenance of a PV system that ensures the registration of all safety information and the design, implementation, management, and control of a risk-benefit safety strategy that meets the requirements established by GPV and the Spanish Agency of Medicine.ICSR management: initial data collection and follow-up in accordance with the company's internal procedures. Assisted in compliance and QC activities, including the timely resolution and documentation of CAPAs.Analyzed and validated variations in the safety information of the technical data sheets (TDS), product information leaflet (PIL), and the summary of product characteristics (SmPC) prior to their submission to the AEMPS (Local Health Authority).Participated in onboarding sessions to provide PV training to new employees of the company and any third party working on behalf of the marketing company. Monitored vendors' compliance according to local Safety Data Exchange Agreements (SDEAs).Performed as a member of the digital committee to ensure digital projects were correctly built to channel safety information.Signal detection: analyzed key data of adverse events (AE) such as demographics, causality, and seriousness to recognize patterns of potential safety concerns. Compared and contrasted information from safety reports against the PIL and the SmPC of each concomitant product in the report to evaluate potential interactions causing the event. Escalated potential signals to the medical department for their final assessment. Prepared and presented monthly signal reports to be presented in GvP meetings. Show less

Madrid, Community Of Madrid, Spain

On behalf of Janssen - Performed QC and review of ICSRs, including priority, seriousness, causality, and the completeness of narrative according to regulations and sponsors quality standards. Identified, managed, and documented any inconsistency or gap information between the ICSR management and the working instruction/SOPs. Developed, designed, and executed QA programs for the Janssen COVID-19 vaccine for the EMEA region.Ensured the accuracy of GCSRs used to respond to inquiries… Show more On behalf of Janssen - Performed QC and review of ICSRs, including priority, seriousness, causality, and the completeness of narrative according to regulations and sponsors quality standards. Identified, managed, and documented any inconsistency or gap information between the ICSR management and the working instruction/SOPs. Developed, designed, and executed QA programs for the Janssen COVID-19 vaccine for the EMEA region.Ensured the accuracy of GCSRs used to respond to inquiries from HCPs, and consumers.Collaborated with other teams to identify trends and derive solutions to risk minimization. Collected information to keep the QA team updated about the latest changes in the ICSRs evaluation process according to sponsor's guidance.Participated in the implementation of translation modules to be applied to the medical information forms.Monitored the QA team metrics, prepared and analyzed quality reports for management review. Managed positive feedback and reviewed performance data to identify improvements in the process.Collaborated in the update of training material. Show less

Madrid, Community Of Madrid, Spain

On behalf of AstraZeneca - ICSR management: collected and tracked incoming Adverse Events (AE), PQCs and SS for the AstraZeneca COVID-19 Vaccine. Performed follow-up (FU) and ensured correct documentation of safety information into the safety database.Collaborated in the integration of both sponsor and vendor's ICSR management systems.Coordinated, monitored, trained, and certified new team members to go live on production according to the sponsor compliance requirements following… Show more On behalf of AstraZeneca - ICSR management: collected and tracked incoming Adverse Events (AE), PQCs and SS for the AstraZeneca COVID-19 Vaccine. Performed follow-up (FU) and ensured correct documentation of safety information into the safety database.Collaborated in the integration of both sponsor and vendor's ICSR management systems.Coordinated, monitored, trained, and certified new team members to go live on production according to the sponsor compliance requirements following local regulations and quality standards.Provided training and guidance to new joiners. Practiced as a certifier to ensure all criteria and requirements were accomplished by the trainee to go live in production. Show less

Madrid Area, Spain

Searched and gathered reference information through input data from internal sources.Identified new products and updates in the EMEA pharmaceutical market to keep reference databases updated. Updated local database with variations and updates of products from different pharmaceutical forms, routes of administration, therapeutic indication and MC. Classified products, standardized, and group data according to the company hierarchies and business rules. Performed quality control… Show more Searched and gathered reference information through input data from internal sources.Identified new products and updates in the EMEA pharmaceutical market to keep reference databases updated. Updated local database with variations and updates of products from different pharmaceutical forms, routes of administration, therapeutic indication and MC. Classified products, standardized, and group data according to the company hierarchies and business rules. Performed quality control of data and applied corrections as required.Maintained documentation of procedures. Therapeutic areas: Oncology, Respiratory, and Immunology.Participated building database categorizing molecules according their indications, pharmaceutical form, administration route, etc Show less

Madrid Area, Spain

On behalf of Roche - ICSR management: collected and tracked incoming Adverse Events (AE), PQCs and SS for the AstraZeneca COVID-19 Vaccine. Performed FU and correct documentation of safety information into the safety database.Implemented GPV established by EMA and heads of medicines agencies.Managed and reported adverse reactions to medicinal products.Developed and implemented actions following the CAPA system.

Miami, Florida

Assisted in the handling and processing of controlled substances, according to state laws.Processed and interpreted medical prescriptions and hospital orders.Formulated sales logistics strategies for expansion by identifying new potential customers.

Miami/Fort Lauderdale Area

Caracas Area, Venezuela

Caracas, Federal District, Venezuela

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Sciences - Ciencias Farmaceuticas

Pharmacy Technology Program, Pharmacy Technician/Assistant

Ingles

Curso Intensivo De Esl (English As Second Language-Ingles Como Segundo Idioma), English Language And Literature, General

Activities and Societies: 26 niveles culminados