Carlos Ignacio Gutiérrez Renero
Mexico, México
Summary
Experienced Senior Safety Specialist with a strong background in pharmacovigilance. Expertise in monitoring and evaluating adverse drug reactions to ensure compliance with regulatory standards. Skilled in utilizing analytical abilities and meticulous attention to detail when assessing safety data and reporting findings across various therapeutic areas including erectile dysfunction, benign prostatic hyperplasia, hematologic disorders, oncology, osteoporosis, Diabetes Mellitus, and CNS Psychiatry (Depression, Bipolar Disorder, Schizophrenia, Anxiety).
Overview
9
9
years of professional experience
Work History
Senior Safety Specialist
Syneos Health
04.2021 - Current
- Handle of the daily EOD status of the project
- Coordination of workflow of around 200 daily cases to ensure delivery of project/program
- Assisted in the preparation and participated in internal project review meetings as required
- Mentored junior specialists, providing guidance on complex case assessments and report generation.
- Streamlined adverse event reporting processes, enhancing efficiency and reducing turnaround time for investigations.
- Conducted training sessions on pharmacovigilance principles, fostering a culture of safety awareness within the organization.
Safety Specialist I & II
Syneos Health
04.2016 - 04.2021
- Evaluated and processed adverse event reports to ensure compliance with regulatory requirements, over 200 cases monthly
- Triage of both serious and non-serious cases coming from ICSR, VeevaVault, Mosaic or Argus platforms. Over 500 cases monthly.
- Provided training and mentorship to junior staff on best practices in pharmacovigilance processes and systems.
- Proactively identified areas for process improvement within the department, leading initiatives that reduced redundancies and increased overall efficiency.
- Enhanced departmental adaptability by staying current on industry trends, guidelines, and best practices related to pharmacovigilance, enabling proactive adjustments to processes as needed.
Education
Diploma - Administration for non-administrators
Universidad Valle De México, UVM
Mexico06.2023
Bachelor - Biopharmaceutical Chemistry
La Salle University
Mexico City12-2015
Skills
- Fast Learner
- Computer Skills
- Safety training development
- Case processing
- Post-marketing surveillance
- Adverse event reporting
- MedDRA coding
- Teamwork
- Clinical trial management
- Drug safety monitoring
- Staff training
LANGUAGES
Spanish
English
Portuguese
French
Japanese
References
Bibiana, Tinajero, bibiana.tinajero@syneoshealth.com, Syneos Health
INTERNSHIPS
- Social Service at National Institute of Perinatology, Mexico City April 2015 — December 2015
- Assisted in the development and validation of an analytical method for the extraction and quantification of levofloxacin in blood samples of pregnant women using HPLC techniques
Timeline
Senior Safety Specialist
Syneos Health
04.2021 - Current
Safety Specialist I & II
Syneos Health
04.2016 - 04.2021
Diploma - Administration for non-administrators
Universidad Valle De México, UVM
Bachelor - Biopharmaceutical Chemistry
La Salle University
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