Katherine Rozo joya
@katherinerozojoya
Pharmaceutical chemist experienced in pharmacovigilance, regulatory submissions, and clinical research.
ColombiaWhat I'm looking for
I am a pharmaceutical chemist with over four years of experience in pharmacovigilance, regulatory submissions, and clinical research across LATAM. I have worked extensively in GXP environments with strong focus on GVP and GCP, ensuring compliance and quality in clinical documentation and safety reporting.
In my recent role as Sr Site Activation Coordinator, I prepared and customized regulatory dossiers, submitted clinical study documentation to regulatory agencies and ethics committees, and conducted quality reviews of ICFs, IBs and protocols. I also monitored regulatory processes and managed safety reporting including SUSARs, DSURs and case reconciliations for Colombia and Guatemala.
Previously, I supported clinical teams as a Clinical Trials Assistant, maintaining clinical systems, coordinating communications and ensuring documentation quality and compliance. As a Pharmacovigilance Analyst I reported SAEs to LATAM health authorities, developed KPIs for patient programs, supported audits, and updated SOPs to optimize the PV system.
I bring strong attention to detail, strategic thinking, autonomous leadership and effective cross-functional communication. I am passionate about continuous learning across healthcare functions and improving processes through quality systems and metrics-driven approaches.
Experience
Work history, roles, and key accomplishments
IQPrepared and customized regulatory dossiers and submitted clinical study documentation across Colombia, Panama and Guatemala; ensured GCP/GVP compliance and reported SUSARs, DSURs and safety events by agreed deadlines. Generated monthly metrics and conducted quality review of ICFs, IBs and Protocols, improving regulatory submission consistency and timelines.
IQSupported clinical teams by maintaining clinical systems and centralizing project communications, ensuring documentation quality and compliance with SOPs and GCP across study timelines. Acted as primary contact for correspondence and contributed to timely tracking of facility compliance and performance.
Pharmacovigilance Analyst
Laboratorios Biopas
Nov 2020 - Dec 2021 (1 year 1 month)
Managed SAE reporting to LATAM health authorities and sponsors, prepared DSURs/PSURs and KPIs for patient support programs, and supported audits and SOP training to improve PV system compliance. Led deviation investigations and implemented CAPAs to reduce recurrence of non-conformities.
Education
Degrees, certifications, and relevant coursework
INVIMA
Continuing Professional Development, Pharmacovigilance
Completed e-Reporting training as part of the National Pharmacovigilance Program (2021 and 2025).
UCUniversity of California
Professional Certificate, Project Management
Completed coursework in Project Management Principles and Practices in 2024.
UCUniversidad Nacional de Colombia
Pharmaceutical Chemist, Pharmaceutical Chemistry
Completed studies in Pharmaceutical Chemistry at the Facultad de Ciencias, graduating in 2020.
INVIMA
Continuing Professional Development, Regulatory Affairs / Medical Device Surveillance
Completed training in Technovigilance (Post Market Surveillance System for Medical Devices) and Sanitary Registration of Medical Devices in 2019.
SESENA
Continuing Professional Development, Quality Management
Completed courses on Quality Management System in the public sector (NTCGP 1000) and NTC ISO 9001 Internal Quality Audit in 2019.
Tech stack
Software and tools used professionally
Availability
Location
ColombiaAuthorized to work in
Job categories
Skills
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