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Summary

Scientific Director - Qualified Person for Pharmacovigilance - Pharmaceutical Technical Manager - regulatory affair manager - development of scientific and Pharmacovigilance department to support in spain and latin america in the field of radiological contrast media. - qppv in sapain, eu and south america. Regulatory Affairs: - manage the appropriate regulatory submissions and premarket registration, and interact with Health authorities to obtain and maintain product approvals in the eu and international. pharmacology: - University Teacher in 3 faculties: universidad de alcalá de henares, universidad complutense de madrid, universidad camilo josé cela de madrid. medical affairs: - Gynecology, pain, oncology, haematology, adhd, CNS. especialidades: pharmacology, Gynecology, oncology, Virology, Pharmacovigilance, Regulatory Affairs, haematology, adhd, xevmpd, MedDRA

Experiences

Current Experience

  • Pharmacology / Pharmacognosy Associated Teacher


    Since October 2013
    associated Teacher at pharmacology & pharmacogonosy departament, Pharmacy faculty, ucm. Associated Teacher at Pharmacology & Pharmacogonosy Departament, Pharmacy Faculty, UCM.

  • Pharmaceutical Technical Manager / Regulatory Affair


    Since January 2013
    Pharmaceutical Technical Manager: Validation of the quality Documentation, product release, relationship with the manufacturer's quality department Pharmaceutical Technical Manager: Validation of the quality documentation, Product release, Relationship with the manufacturer's quality department

  • Scientific Director - QPPV


    Since March 2009
    scientific responsible on behalf of the Laboratory before the Health authorities. qppv - Pharmacovigilance responsible on behalf of the Laboratory before the Health authorities. bussisnes development manager Scientific responsible on behalf of the laboratory before the health authorities. QPPV - Pharmacovigilance responsible on behalf of the laboratory before the health authorities. Bussisnes Development Manager

  • Pharmacovigilance / Medical-scientific / Regulatory affair Consultant


    Since June 2008
    Consultant in the following areas medical-Scientific Advisor in the following areas: gynaecology area, mainly for contraception and hormone replacement therapy, iron therapy (anaemia) and phytotherapy (from 2004). primary care and cardiovascular area mainly in Hypertension, analgesia, Inflammation and anaemia (from 2007). regulatory affair: regulatory advisor to internal customers, mainly Marketing department and Business Development department. draft of summary of product characteristics, patient information sheet and Expert's reports. Sales-force Training. medical-Scientific Advisor to the Marketing departments. Health Care Compliance. medical and Scientific Advisor. Clinical research: Researcher´s selection and monitoring, pharmacoepidemiologic studies. Data Analysis, submission, poster preparation, speaker preparation and , slide development. Pharmacovigilance: Pharmacovigilance affair. redaction of periodical security reports. qppv; Pharmacovigilance systems; electronic reporting of icsrs; extended ev medicinal product dictionary (xevmpd) Consultant in the Following areas Medical-scientific advisor in the following areas: Gynaecology area, mainly for contraception and hormone replacement therapy, iron therapy (anaemia) and phytotherapy (from 2004). Primary care and cardiovascular area mainly in hypertension, analgesia, inflammation and anaemia (from 2007). Regulatory affair: Regulatory advisor to internal customers, mainly marketing department and business development department. Draft of Summary of Product Characteristics, Patient information sheet and Expert's Reports. Sales-force training. Medical-scientific advisor to the Marketing Departments. Health Care Compliance. Medical and Scientific advisor. Clinical research: Researcher´s selection and monitoring, pharmacoepidemiologic studies. Data analysis, submission, poster preparation, speaker preparation and , slide development. Pharmacovigilance: Pharmacovigilance affair. Redaction of Periodical Security Reports. QPPV; Pharmacovigilance systems; electronic reporting of ICSRs; eXtended EV Medicinal Product Dictionary (XEVMPD)

Past Experience

  • Medical Advisor

    May 2004 --- June 2008
    medical-Scientific Advisor in the following areas: gynaecology area, mainly for contraception and hormone replacement therapy, iron therapy (anaemia) and phytotherapy. primary care and cardiovascular area mainly in Hypertension, analgesia, Inflammation and anaemia. snc (depression, adhd, bipolar dissorder). regulatory affair: responsable of human drug promotion and publicity. Sales-force Training. medical-Scientific Advisor to the Marketing department. Health Care Compliance. Scientific Advisor to the Business Development department. medical-Scientific Advisor to the international department aimed at the product commercializing in portugal and south america.

  • Manager - Pharmaceutical Regulation Service. Section for the Supply of Foreign Drugs

    January 2001 --- January 2004
    Technician functions: dispensation of drugs, supervision of the storage and of drugs, participation in the project pharmacotherapeutic guide of primary care for the community of madrid, procedure management of foreign drugs for patients within the community of madrid before the ministry of Health, information on national and foreign drugs, information on tropical and traveller’s diseases.participation in programs on publich Health, “traveller’s guide”; “information program on Health and trips aimed at the office of Pharmacy”.

  • Teacher

    January 2000 --- January 2003
    Tutor of on-line course "on-line course on applied Pharmaceutical Care." on-line and telephone tutorships. content preparation.

Knowledge

LinkedIn Assessment :
PharmacovigilanceMedical DirectorspharmacologyRegulatory affairseCTDMedical writingHealthcare AdvertisingScientific CommunicationsNutraceuticalsXEVMPDScientific ManagementRadiologyoncologyRegulatory submissionsMedical affairsHealthcareClinical researchPharmaceutics

Education

  • EudraVigilance – electronic reporting of ICSRs certificate in Pharmacovigilance from EMA (European Medicines Agency) in 2012
  • XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) certificate in Drug regulatory from EMA (European Medicines Agency) in 2012
  • • Information day on the Ministerial order of border health control by the pharmaceutical inspection in Pharmacy from AEMPS (Agency on Medicinal Products and Medical Devices) in 2011
  • • Aranzadi´s Health Law Forum. Update in Pharmaceutical legislation in Pharmacy, Legislation, Regulatory from Eupharlaw in 2008
  • Especialista in Anticoncepcion hormonal from 2007 Sociedad Española de Contracepción Valencia in 2007
  • Update on Contracption in Medicine, Gynecology, Pharmacology from Sociedad Española de Contracepción Valencia in 2007
  • Specialist in Pharmaceutilca Medicine in Medicine, Pharmacy from Universidad Complutense de Madrid in 2006
  • PhD in Pharmacy in Pharmacology - Pharmaconogsy from Universidad Complutense de Madrid in 2004
  • Pharmacotherapeutic Update Course in Pharmacology from Health Department ­ Government of Madrid in 2003
  • Degree thesis. in Pharmacology - Virology from Universidad Complutense de Madrid in 2000
  • Pharmaceutical Care in Pharmacy from Peters Institute of Pharmaceutical Care. University of Minnesota in collaboration with the School of Pharmacy of Madrid in 1999
  • Licentiate degree in Pharmacy from Universidad Complutense Madrid in 1997

Training and Certification

  • EudraVigilance – electronic reporting of ICSRs certificate in 0000 Certification
  • XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) certificate in 0000 Certification

Area / Region

Madrid, España

Others

Driving License
  • Yes

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