Arcelia Alvarez
Hidalgo
Summary
Bachelor of Biology, Pharmacy and Chemistry with 13 years of experience working in Clinical Research Organizations (pharmacovigilance and data management), ensuring high quality standards in clinical trials phase I to IV for a wide variety of therapeutic areas such as Oncology, Women's Health, Metabolic Diseases, Central Nervous System, Immunology & Rheumatology, and Rare Diseases, mainly.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Supervisor, Pharmacovigilance
ICON Plc
10.2021 - Current
- Formerly Senior Drug Safety Coordinator.
- Subject matter expertise for any pharmacovigilance-related activities.
- Project lead of one of the biggest portfolios (30 studies) in the department.
- Achieving 98% safety reporting compliance according to local regulation for both expedited and periodic reports during 3 years.
- Project management in accordance with company standards, regulatory requirements, and contractual obligations to sponsors.
- Review of budget and contracts to ensure adherence to financial guidelines.
- Identifying operational inefficiencies and implementing corrective measures, leading to an overall increase in effectiveness.
- Developing and implementation of Standard Operating Procedures, Work Instructions and Guidelines to streamline operations.
- Coordinating interdepartmental activities (e.g., listing review, quality control, quality assurance, audits, miscellaneous project activities).
- Delivery of integrated strategic safety expertise to internal and external customers throughout the project life cycle.
- Cultivating strong relationships with clients or stakeholders through consistent communication and excellent service delivery.
- Training and mentoring newly hired staff.
- Assisting with creation, coordination, and delivery of training to staff.
Drug Safety Coordinator
ICON Plc
04.2021 - 09.2021
- Project lead of one of the biggest portfolios (24 studies) in the department.
- Achieving 98% safety reporting compliance according to local regulation for both expedited and periodic reports during 3 years.
- Project management in accordance with company standards, regulatory requirements, and contractual obligations to sponsors.
- Review of budget and contracts to ensure adherence to financial guidelines.
- Coordinating interdepartmental activities (e.g., listing review, quality control, quality assurance, audits, miscellaneous project activities).
- Delivery of integrated strategic safety expertise to internal and external customers throughout the project life cycle.
- Cultivating strong relationships with clients or stakeholders through consistent communication and excellent service delivery.
- Training and mentoring newly hired staff.
Senior Drug Safety Associate
ICON Plc
04.2019 - 03.2021
- Oversight of 24 projects for 15 different clients as Safety Reporting Group Lead with 98% compliance in safety submissions and 106% net utilization.
- Performing safety submissions to Competent Authorities, Ethic Committees, and Investigators to ensure regulatory compliance.
- Completion of all departmental project activities accurately in accordance with company standards, regulatory requirements, and contractual obligations to sponsors.
- Interaction with client and functional leads about safety reporting activities.
- Training and mentoring newly hired staff.
Drug Safety Associate
ICON Plc
08.2015 - 03.2019
- Submission of expedited and periodic reports to Competent Authorities, Ethics Committees, and Investigators to ensure regulatory compliance according to local requirements and contractual responsibilities.
- Management of activities during the set-up, maintenance, and close-out stage in a project lifecycle.
- Top performer with the highest number of safety submissions in 2016-2017 with 100% compliance.
- Assignment as official trainer for interns leading to their successful application as permanent employees.
Clinical Data Associate I/ II
INC Research
07.2011 - 08.2014
- Reviewing and processing clinical data to ensure accuracy and consistency of clinical databases through electronic and manual validation.
- Collaborating in start-up, conduct and close out phases.
- 4 interim analyses and 2 locked databases.
- Performing activities in a project as clinical coder.
Clinical Data Associate I
Kendle International Inc.
02.2010 - 06.2011
- Reviewing and processing clinical data to ensure accuracy and consistency of clinical databases through electronic and manual validation.
- Collaborating in start-up, conduct and close out phases.
- 2 interim analyses and 1 locked database.
Education
Master of Science - Health Administration
UTEL University
Mexico City (Remote)04.2025
Bachelor of Biology, Pharmacy and Chemistry -
Universidad Nacional Autónoma De México
06.2008
Museology and Restorer Museographer Technician Assistant -
Escuela Nacional Preparatoria
06.2003
Skills
- Solid knowledge of ICH, GCP and GVP
- Drug Safety Reporting (NA, LatAm, EU, APAC)
- Safety/clinical databases (Argus, Oracle, RAVE)
- Clinical Data Management (Clinical coding)
- Quality Assurance
- Quality Control
- Mentoring
- Attention to detail
- Productivity and efficiency
- Ability to develop teamwork
- Time management
- Work ethic
Certification
- Qualified Professional in Pharmacovigilance and Drug Safety, InnoVigilance International Academy, 2021
- ACRP-CP Certified Professional, Association of Clinical Research Professionals, 2019, 2021
Affiliations
- International Society of Pharmacovigilance, 2023
- American Society for Quality, 2023
- American Society of Pharmacovigilance, 2021, 2022
- Association of Clinical Research Professionals, 2018, 2019
Languages
Spanish
Bilingual or Proficient (C2)
English
Advanced (C1)
French
Beginner (A1)
Personal Information
Title: B. Pharm.
Timeline
Supervisor, Pharmacovigilance
ICON Plc
10.2021 - Current
Drug Safety Coordinator
ICON Plc
04.2021 - 09.2021
Senior Drug Safety Associate
ICON Plc
04.2019 - 03.2021
Drug Safety Associate
ICON Plc
08.2015 - 03.2019
Clinical Data Associate I/ II
INC Research
07.2011 - 08.2014
Clinical Data Associate I
Kendle International Inc.
02.2010 - 06.2011
Master of Science - Health Administration
UTEL University
Bachelor of Biology, Pharmacy and Chemistry -
Universidad Nacional Autónoma De México
Museology and Restorer Museographer Technician Assistant -
Escuela Nacional Preparatoria
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