Office 365
LAURA ELIZABETH TRIANA TRIANA
Doctor Of Veterinary Medicine
Bogotá,
Summary
Dynamic pharmacovigilance professional with 10 years of experience in global pharmacovigilance (PV), clinical safety, and case management. Proven expertise in PV regulations, global compliance, and technological solutions across multiple PV functional areas. Adept at leading cross-functional collaborations, optimizing safety systems, and driving automation to enhance operational efficiency. Strong leadership, analytical, and problem-solving skills with a track record of ensuring regulatory compliance and patient safety in high-pressure environments.
Overview
10
10
years of professional experience
3
3
Languages
Work History
Senior Specialist, Drug Safety - Clinical Safety Strategic Operations (CSSO)
MSD Colombia
01.2023 - Current
- Provide subject matter expertise in regulatory safety, system configuration, and operational processes
- Spearhead the transition from Oracle Argus to Veeva Vault Safety, ensuring seamless data migration and system validation
- Oversee ICSR processing operations, collaborating with global CROs and vendors from case receipt to submission
- Ensure compliance with FDA, ICH, EU GVP, and global PV regulations
- Lead cross-functional collaborations with global teams, including CORE, ICMR, CSRM, and Medical Writing, to optimize safety reporting
- Support regulatory compliance initiatives, including audit CAPAs, health authority responses, and metric monitoring
Safety Data Manager, Global Pharmacovigilance Case Management (GPVCM)
MSD Colombia
05.2022 - 12.2022
- Provided strategic leadership for global case management teams across Poland, China, Costa Rica, and Colombia
- Led automation initiatives, increasing efficiency by 30% and eliminating human errors
- Managed integration projects for Japan PV compliance under evolving regulatory landscapes
- Developed protocol amendment tracking tools to ensure accurate global regulatory reporting
Lead Safety Data Specialist, GPVCM
MSD Colombia
07.2020 - 04.2022
- Led Study Data Entry Support teams and developed PV training programs for global teams
- Managed PV integration during M&A activities, ensuring regulatory compliance for 15+ company acquisitions
- Automated manual processes using Tibco Spotfire, Excel VBA, and Office 365 tools
Senior Safety Data Specialist, GPVCM
MSD Colombia
05.2018 - 06.2020
- Functioned as point of contact for global study configurations and unblinding processes
- Developed SOPs, user manuals, and training guides to ensure PV best practices
- Designed and deployed a global notification app for PV operations using PowerApps and SharePoint
Safety Data Specialist, GPVCM
MSD Colombia
03.2015 - 04.2018
- Managed case processing and safety data handling in the global safety database
- Trained and mentored new hires, ensuring the highest data quality and compliance standards
Education
Doctor of Veterinary Medicine -
National University of Colombia
Bogotá 05.2001 -
Skills
- Pharmacovigilance & Clinical Safety (Case Processing, ICSR, Signal Detection)
- Regulatory Compliance (FDA, ICH GCP, EU GVP, CFR)
- Global PV Operations & Submissions
- Clinical Trials & Safety Data Management
- SaaS Implementation & Process Automation
- Leadership & Stakeholder Collaboration
- Project & Change Management
- Data Analytics & Risk Mitigation
Technicalandlanguageskills
Argus Safety, Veeva Vault, Spotfire, PowerApps, VBA, Office 365, Native, C1, A2
Software
Argus
Veeva Vault
VBA
PowerApps
Spotfire
Timeline
Senior Specialist, Drug Safety - Clinical Safety Strategic Operations (CSSO)
MSD Colombia
01.2023 - Current
Safety Data Manager, Global Pharmacovigilance Case Management (GPVCM)
MSD Colombia
05.2022 - 12.2022
Lead Safety Data Specialist, GPVCM
MSD Colombia
07.2020 - 04.2022
Senior Safety Data Specialist, GPVCM
MSD Colombia
05.2018 - 06.2020
Safety Data Specialist, GPVCM
MSD Colombia
03.2015 - 04.2018
Doctor of Veterinary Medicine -
National University of Colombia
05.2001 -
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