Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Marisol Alvarez

Pharmaceutical-Chemist
Guadalajara,Jalisco

Summary

I have a clinical studies diploma. Experience in the pharmaceutical industry mainly in Pharmacovigilance and Regulatory Affairs. I have a good level of English C1, attention to detail, ability in documentation edition, perfectly teamwork ability, use of Microsoft office tools as word, excel, one drive, power point, as well as regulatory databases as LSMV-LifeSphere Multivigilance, eCTD system, capable to learn new technologies, clinical trials training, training in medical terminology (MedDRA). My best skills are organization, planification, responsibility, teamwork, adaptability, and analytical processes.

Overview

18
18
years of professional experience

Work History

Pharmacovigilance Analyst

Fresenius Kabi México S.A. de C.V.
Zapopan, Jalisco
04.2018 - 06.2025
  • Application of the normativity in Pharmacovigilance through conducting and reviewing PSURs, RMPs, adverse reaction management, reviewing registry modifications for safety reasons, systematic literature searches, etc.

Regulatory Affairs Specialist

Fresenius Kabi México S.A. de C.V.
01.2011 - 04.2018
  • Review and compilation of information for dossier submission to local health authority through application of regulatory law, basic ICH guidelines and FDA submissions, eCTD Management System and basic knowledge of clinical trials.

Analytical Methods Development and Validation Analyst

PiSA Farmacéutica Mexicana S.A. de C.V.
01.2010 - 12.2010
  • Development and validation of new analytical methodology though pharmacopoeia methods.

Regulatory Affairs Specialist/Analytical Methods Development and Validation Analyst/Stability Analyst

Vitae Laboratorios S.A. de C.V.
01.2009 - 12.2009
  • Analysis and compilation of information for submission of new drug licenses on Latin America countries.
  • Development and Validation of new analytical methodology.
  • Analysis of stability products.

Raw Material Analyst

Ultra Laboratorios S.A. de C.V.
09.2007 - 03.2008
  • Analysis of raw materials for productions of finished product.

Education

Diploma of Higher Education - Clinical Trials

INSTITUTO EUROPEO DE ESTUDIOS EMPRESARIALES
Guadalajara, Jalisco
11.2024 - 01.2025

NVQ Level 2 - LSMV-LifeSphere Multivigilance

Fresenius Kabi
Mexico
02.2024 - 02.2024

Bachelor´s Degree - Pharmacobiological Chemist

Universidad de Guadalajara
Guadalajara, Jalisco
02.2002 - 07.2007

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - undefined

FDA Online course

eCTD Manager System: Full Training - undefined

WhoDrug: Basic Training - undefined

MedDRA: Basic Training - undefined

Skills

organization

pacification

responsibility

undefined

Languages

Spanish
Native
English
Advanced (C1)

Timeline

Diploma of Higher Education - Clinical Trials

INSTITUTO EUROPEO DE ESTUDIOS EMPRESARIALES
11.2024 - 01.2025

NVQ Level 2 - LSMV-LifeSphere Multivigilance

Fresenius Kabi
02.2024 - 02.2024

Pharmacovigilance Analyst

Fresenius Kabi México S.A. de C.V.
04.2018 - 06.2025

Regulatory Affairs Specialist

Fresenius Kabi México S.A. de C.V.
01.2011 - 04.2018

Analytical Methods Development and Validation Analyst

PiSA Farmacéutica Mexicana S.A. de C.V.
01.2010 - 12.2010

Regulatory Affairs Specialist/Analytical Methods Development and Validation Analyst/Stability Analyst

Vitae Laboratorios S.A. de C.V.
01.2009 - 12.2009

Raw Material Analyst

Ultra Laboratorios S.A. de C.V.
09.2007 - 03.2008

Bachelor´s Degree - Pharmacobiological Chemist

Universidad de Guadalajara
02.2002 - 07.2007

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - undefined

FDA Online course

eCTD Manager System: Full Training - undefined

WhoDrug: Basic Training - undefined

MedDRA: Basic Training - undefined

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Marisol Alvarez Pharmaceutical-Chemist