Summary
Overview
Work History
Education
Skills
Timeline
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Estivalys Nicole Lugo Cruz

Estivalys Nicole Lugo Cruz

Biological Pharmaceutical Chemist
Mexico City

Summary

One of the objectives I have as a professional is to improve people's quality of life, contributing to the health system by promoting patient safety. I am very disciplined and precise. Addresses problems and tasks in depth and detail. I like to operate based on facts and data, although I can also go beyond that and show creative thinking. Perseverance and determination are fundamental qualities in me.

Overview

5
5
years of professional experience
6
6
years of post-secondary education
3
3
Languages

Work History

Senior Pharmacovigilance Reporting Associate

ICON Plc
05.2025 - Current
  • Maintains own current knowledge of and compliance with local safety regulations for local country or countries.
  • Perform distribution of periodic safety reports for local and/or regional needs.
  • Perform the dissemination of urgent safety communications and DILs required
  • Ensures that local safety activities are documented and filed or archived in line

Senior Drug Safety Associate

ICON plc
01.2023 - 04.2025
  • Act as a security reporting processor, providing management support as designated, responsible for security reporting or security reporting intelligence activities on assigned projects, working with a customer-centric approach and an audit and inspection-ready mindset. Experience of these activities in the LATAM region.
  • Evaluated emerging trends in drug safety regulations, providing expert recommendations to senior management for strategic planning purposes.
  • Served as a key liaison between the company and external partners, fostering collaborative relationships that benefited overall drug safety operations.
  • Ensured alignment with global pharmacovigilance guidelines through regular updates on internal procedures and protocols.
  • Championed best practices in pharmacovigilance, establishing a culture of continuous improvement within the drug safety department.
  • Developed comprehensive training materials and conducted workshops for junior team members to enhance their drug safety knowledge and skills.
  • Contributed significantly towards successful regulatory inspections through meticulous preparation and seamless coordination among involved teams.

Medical Affairs Specialist

ICON plc
01.2021 - 12.2023
  • Contribute to the preparation of the Medical Monitoring Report/Safety Monitoring report, participation in the safety data review service (listing review, patient profile review, coding review), support in the development of Medical Monitor activities.

Clinical Pharmacist

Hospital San Angel Inn - Chapultepec
01.2021 - 12.2021
  • Preparation of active pharmacovigilance activities in hospitalized patients and in clinical and hospital pharmacy activities: Pharmaceutical care (detection of medication errors and drug-related problems (prescription, transcription, administration). Pharmacovigilance activities: SRAM detections, drug interaction detection, SRAM report to the regulatory authority

Pharmacotherapeutic Monitoring Advisor

Integramed
01.2020 - 01.2021
  • Monitoring of medications for patients with chronic diseases, based on: Generation of therapeutic adherence strategies, pharmaceutical care: detection of medication errors, detection of drug-related problems, pharmacovigilance activities: detection of SRAMs, detection of drug interaction, Health Education, through the development of educational material, analysis of the prescription during dispensing.

Education

Master's - Clinical Pharmacy

Universidad Nacional Autónoma De México
Mexico City, Mexico
08.2024 - Current

Bachelor's degree - Biological Pharmaceutical Chemist

Universidad Nacional Autónoma De México
Mexico City, Mexico
08.2016 - 12.2021

Skills

MS Office

Argus

Vigiflow

SAP business one

CRF/Veeva

Time management

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Timeline

Senior Pharmacovigilance Reporting Associate

ICON Plc
05.2025 - Current

Master's - Clinical Pharmacy

Universidad Nacional Autónoma De México
08.2024 - Current

Senior Drug Safety Associate

ICON plc
01.2023 - 04.2025

Medical Affairs Specialist

ICON plc
01.2021 - 12.2023

Clinical Pharmacist

Hospital San Angel Inn - Chapultepec
01.2021 - 12.2021

Pharmacotherapeutic Monitoring Advisor

Integramed
01.2020 - 01.2021

Bachelor's degree - Biological Pharmaceutical Chemist

Universidad Nacional Autónoma De México
08.2016 - 12.2021

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Estivalys Nicole Lugo CruzBiological Pharmaceutical Chemist