Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Intern

Baridilo Kponi

Lawrenceville,GA

Summary

Self-motivated graduate currently seeking a position in drug safety, and pharmacovigilance specialist with four plus years of experience in clinical research and regulatory affairs. Experienced healthcare professional in patient care and clinical research focused on adverse event reporting of investigational, post-marketed drugs, safety reporting, as well as aggregate safety monitoring, Exceptional knowledge of medical terminology, and medical narrative writing. Trained in pharmacovigilance and working with global safety databases and ensuring compliance with global regulatory requirements.

Overview

12
12
years of professional experience

Work History

Intern

Drug and Safety, Sollers
08.2022 - Current
  • Sollers is an educational organization specializing in graduate certificate programs in advanced drug safety and pharmacovigilance, clinical research, and clinical trial management.
  • Delivering accurate and consistent medical coding with MedDRA, UMC WHODrug, or company-specific dictionary is clear, appropriate, and complete based upon the investigator’s entry on the CRF and coded in compliance with all processes, guidelines and conventions
  • Data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database
  • Perform quality reviews for adverse events (AEs), serious adverse events (SAEs), and serious unexpected serious adverse reactions (SUSARs)
  • Document case summaries of gathered information into a concise clinical narrative, assess causality, and write CIOMS comments if required as well as Performing Quality Control on cases processed by other team members
  • Manages business partner exchange of AE reports in accordance with safety data exchange agreements and performs reconciliation
  • Provide scientific support to the project team involved in the application of cognitive computing and other artificial intelligence capabilities to be used in the conduct of pharmacovigilance
  • Assist with ensuring that periodic and expedited safety reports comply to both internal and regulatory timelines with strong knowledge of periodic reporting including PADER/DSUR/PSUR/PBRER
  • Knowledge of general clinical research and of the pharmaceutical industry
  • Thorough understanding of Regulations, GCP, and ICH Guidelines as they apply to the coding of medical terminology.

Operations – Clinical Coordinator/Clinical Engineering

Gwinnett Medical Center
01.2011 - 09.2015
  • Gwinnett Health system provides health service across North Georgia, Analyzed patient documentation process and procedure
  • Designed the metrics from patient recruitment in the hospital till the follow-up
  • Handled consent forms and care of patients in the hospital
  • Completed the assigned projects within the timeframe
  • Supported statistical data analysis of the patient feedback
  • Supported the top management in proper analysis and submission of data regarding patient satisfaction leading to significant increase in the patient satisfactory level
  • Performing site drug accountability, checking that the study drugs are appropriately stored and dispensed, ensuring the drug dispensing records & temperature logs are up to date and monitoring expiry dates of study supplies
  • Organized and coordinated special projects; Active involvement in strategizing plans, executing actions, meeting schedules and monitoring results
  • Discussed about open queries in EDC system and guide the site staff to answer those queries
  • Assist with AE/SAE reconciliation prior to clinical trial database closure
  • Perform initial assessment to determine if the case meets criteria for adverse event

Education

Basic Medical Science

Caribbean Medical University
Curacao

Associate of Applied Science - Biomedical Engineering Technology

Chattahoochee Technical College

Certification- Advanced Drug Safety and Pharmacovigilance, in progress -

Sollers College
05.2023

Master’s - Business Administration, Healthcare

Plymouth State University
2018

Bachelor of Science - Electronics Engineering Technology

University of Arkansas Grantham
2015

Skills

  • Clinical Research
  • Quality Control/ Quality Assurance
  • Drugs Safety/ Pharmacovigilance
  • Signal Detection & Case Processing
  • Basic knowledge of Microsoft Office applications
  • Knowledge of MedDRA dictionaries, EMA, GVP guidelines, ICH-GCP, SOP & FDA regulations
  • Hands on experience on Argus Safety Database
  • Hands on experience on Trial Master file and reconciling eTMF; proficiency in CTMS, SharePoint
  • Knowledge: Clinical Knowledge of therapeutic area, patient populations and drug class
  • Knowledge of GXP Scope (Good Pharmacovigilance Practice)
  • Knowledge: Clinical Knowledge of therapeutic area, patient populations and drug class
  • Knowledge of GXP Scope (Good Pharmacovigilance Practice)

Affiliations

Georgia Association of Healthcare Executives, American College of Preventive Medicine, Clinical Research Professionals, Society of Clinical Research Associates

Work Authorization: Authorized to work for any US employer without sponsorship

Timeline

Intern

Drug and Safety, Sollers
08.2022 - Current

Operations – Clinical Coordinator/Clinical Engineering

Gwinnett Medical Center
01.2011 - 09.2015

Basic Medical Science

Caribbean Medical University

Associate of Applied Science - Biomedical Engineering Technology

Chattahoochee Technical College

Certification- Advanced Drug Safety and Pharmacovigilance, in progress -

Sollers College

Master’s - Business Administration, Healthcare

Plymouth State University

Bachelor of Science - Electronics Engineering Technology

University of Arkansas Grantham

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Baridilo Kponi