Onyebuchi Ogbuagu
@onyebuchiogbuagu
Experienced pharmacovigilance safety physician ensuring patient safety and regulatory compliance.
What I'm looking for
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
Senior Medical/Safety Reviewer
Confidential CRO / Sponsor
Mar 2020 - Present (5 years 7 months)
Conducted medical reviews of ICSRs and SAEs, contributed to PSURs/DSURs/RMPs, and supported signal detection and benefit–risk assessments to ensure regulatory compliance and patient safety.
Physician (Weekend Call)
Vohra Wound Physicians
Nov 2017 - Present (7 years 11 months)
Provided wound care management and clinical oversight across care facilities, maintained documentation and compliance with institutional standards to ensure patient safety.
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.
Principal Investigator / Consultant
Axon Clinical Research
Nov 2017 - Feb 2019 (1 year 3 months)
Provided medical oversight for clinical trials, ensured protocol compliance and subject safety, and reviewed adverse event documentation and medical narratives.
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.
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.
Research Fellow
Johns Hopkins University School of Medicine
Jul 2012 - Jan 2013 (6 months)
Conducted clinical research activities contributing to study design, data analysis, and support for publications and presentations with medical and statistical input.
Education
Degrees, certifications, and relevant coursework
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.
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
Availability
Location
Authorized to work in
Job categories
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