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Onyebuchi Ogbuagu

@onyebuchiogbuagu

Experienced pharmacovigilance safety physician ensuring patient safety and regulatory compliance.

United States
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What I'm looking for

I am seeking a pharmacovigilance or clinical safety role where I can apply medical review expertise, mentor teams, contribute to signal detection and regulatory submissions, and support patient-centered safety strategies.

I am a detail-oriented Pharmacovigilance Safety Physician with over seven years of experience in medical review, clinical safety assessment, and regulatory compliance. I apply ICH-GCP, FDA, EMA, and MHRA standards to ensure data integrity and patient safety across investigational and marketed products.

My work includes medical review of ICSRs and SAEs, signal detection, benefit–risk assessment, and contribution to aggregate safety reports such as PSURs, DSURs, and RMPs. I have served as a medical point of contact for cross-functional global pharmacovigilance teams and mentored junior reviewers and medical staff.

I bring hands-on clinical experience from wound care and clinical trial oversight, plus technical proficiency with Argus Safety, MedDRA, WHO Drug Dictionary, eCTD, EDC systems, and safety database review. I am committed to collaborative problem-solving and clear scientific communication that supports regulatory submissions and patient-centered safety outcomes.

Experience

Work history, roles, and key accomplishments

AR

Medical/Safety Reviewer

Axon Clinical Research

Mar 2018 - Feb 2020 (1 year 11 months)

Performed comprehensive medical review of adverse events and SAEs, supported signal detection and RMP/DSUR preparation, and ensured MedDRA coding and global reporting timelines compliance.

AR

Sub-Investigator / Consultant

Axon Clinical Research

Jan 2015 - Dec 2017 (2 years 11 months)

Assisted in trial conduct, subject evaluations, and data verification while collaborating with investigators and sponsors to maintain GCP compliance.

Johns Hopkins University School of Medicine logoJM

Senior Research Coordinator

Johns Hopkins University School of Medicine

Feb 2013 - Jan 2015 (1 year 11 months)

Managed daily operations of clinical research studies, collected and reviewed adverse event data, and supported study start-up, consent, and regulatory documentation.

Education

Degrees, certifications, and relevant coursework

Johns Hopkins University logoJU

Johns Hopkins University

Master of Public Health, Public Health

Completed a Master of Public Health at Johns Hopkins University, focusing on public health principles and research methods.

NU

Nnamdi Azikiwe University

Bachelor of Medicine, Bachelor of Surgery, Medicine

Earned the Bachelor of Medicine, Bachelor of Surgery (MBBS) degree with clinical training in medical and surgical disciplines.

Tech stack

Software and tools used professionally

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Onyebuchi Ogbuagu - Senior Medical/Safety Reviewer - Confidential CRO / Sponsor | Himalayas