Jessica Gasca, PhD
Clinical Development Department at Laboratorios Ojer Pharma- Claim this Profile
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Español Native or bilingual proficiency
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Inglés Full professional proficiency
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Francés Elementary proficiency
Topline Score
Bio
Credentials
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Good Clinical Practice (GCP-ICH)
Andalusian Initiative for Advanced Therapies (IATA), SpainApr, 2018- Oct, 2024 -
Good Laboratory Practice (GLP)
Andalusian Initiative for Advanced Therapies (IATA), SpainApr, 2018- Oct, 2024
Experience
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Laboratorios Ojer Pharma
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Development Department
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May 2023 - Present
Development of innovative pharmaceutical products in dermatology. Development of innovative pharmaceutical products in dermatology.
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PharmaLex
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Belgium
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Accounting
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Senior Manager Pharmacovigilance
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Jul 2022 - Jan 2023
- Coordinating and performing international GVP audits. PV audits at or on behalf of client company: PV System internal audits, Affiliate audits, License partner/distributor audits, Qualification of PV vendor audits. - Design and implentation of PV audit system. -Preparation, management and follow-up of CAPA plan related to PV audits. - Coordinating and performing international GVP audits. PV audits at or on behalf of client company: PV System internal audits, Affiliate audits, License partner/distributor audits, Qualification of PV vendor audits. - Design and implentation of PV audit system. -Preparation, management and follow-up of CAPA plan related to PV audits.
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GCP and GVP Inspector
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Dec 2019 - Jul 2022
Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) Inspections Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) Inspections
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Spanish Clinical Research Network (SCReN)
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Spain
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Hospitals and Health Care
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1 - 100 Employee
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Clinical Research Associate (CRA)
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Feb 2018 - Aug 2019
Therapeutic areas: Oncohematology; Endocrinology (Type 2 diabetes, primary hypercholesterolemia); Cardiology; Nephrology; Gastroenterology; Hepatology - Clinical trial monitoring (phases II-III-IV ). -Evaluation of protocols, consent forms and other clinical study documents at Andalusian Biomedical Research Ethics Coordinating Commitee (CCEIBA), Sevilla (Spain). - International and national multicentre observational studies monitoring. - Ensuring all clinical studies are conducted, recorded and reported in accordance with the protocols, Standard Operating Procedures (SOPs), Good Clinical Practices (ICH-GCP) and other applicable regulatory requirements. Checking clinical site activities, make on-site visits, review Case Report Forms (CRFs) and communicate with Clinical Research Coordinators. - Pharmacovigilance tasks. - Evaluation of Clinical Trials and Design of Protocols. - Elaboration of SOPs. Show less
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Research Fellow
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Mar 2011 - Sep 2017
Therapeutic areas: Oncology (Breast Cancer, Prostate Cancer and Bladder Cancer). - Preclinical and clinical research proyects. - Data analysis, interpretation and clinical relevance. - Participation in research projects as a collaborator investigator. - Experience in treatment of biological and genetic samples in clinical trials: Molecular Biology Techniques. - Searching and reading scientific literature. - Writing scientific reports and publication in scientific journals. - International and National Congress assistance and contributions with posters and oral communication. Show less
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Karolinska Institutet
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Sweden
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Higher Education
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700 & Above Employee
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Visiting Researcher
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Sep 2016 - Dec 2016
Therapeutic areas: Oncology (Breast Cancer and Liver Cancer). Pharmacoepigenetics Group - Department of Physiology and Pharmacology (FYFA) Identification of epigenetic mechanisms and biomarkers involved in drug response. Therapeutic areas: Oncology (Breast Cancer and Liver Cancer). Pharmacoepigenetics Group - Department of Physiology and Pharmacology (FYFA) Identification of epigenetic mechanisms and biomarkers involved in drug response.
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Prescriptionist
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United States
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Biotechnology Research
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Community pharmacist
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Jun 2011 - Nov 2014
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Community pharmacist
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Mar 2010 - Sep 2010
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Hospital pharmacist (Training Placements)
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May 2009 - Jul 2009
- Performs primary functions of the Registered Pharmacist in interpreting and evaluating medication orders and prescriptions - Prepare and dispense medications in accordance with established hospital procedure - Develop and promote collaborative and collegial relationships with nurses, physicians, and interdepartmental personnel as they relate to the pharmaceutical care of the patients Hospital Pharmacist - Performs primary functions of the Registered Pharmacist in interpreting and evaluating medication orders and prescriptions - Prepare and dispense medications in accordance with established hospital procedure - Develop and promote collaborative and collegial relationships with nurses, physicians, and interdepartmental personnel as they relate to the pharmaceutical care of the patients Hospital Pharmacist
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Student Research Collaboration Grant (Spanish Government)
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Sep 2008 - Jun 2009
Natural products with antitumor effects Natural products with antitumor effects
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Internal student
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Sep 2007 - Jun 2008
Natural products with antitumor effects Natural products with antitumor effects
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Education
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Universidad de Sevilla
MSc, Clinical Trial -
Universidad de Sevilla
Ph.D, Molecular Biology and Biomedicine -
University of Seville, Spain
Master, Biomedical Research -
Postgraduate School of University of Granada, Spain
Master, Pharmaceutical care in HIV/AIDS patients -
Faculty of Pharmacy, University of Seville, Spain
Degree, Pharmacy -
ENEB - Escuela de Negocios Europea de Barcelona
Master of Business Administration - MBA, Business Administration and Management