Henry Ogbeifun
San Antonio
Summary
Results-driven physician-scientist with extensive experience in pharmacovigilance, drug safety, and risk management. Spearheaded safety initiatives for oncology programs, ensuring compliance and patient safety while mentoring junior scientists in case processing and aggregate safety reporting.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Scientist
IDRx Pharmaceuticals
12.2023 - Current
- Author and review DSURs, PSURs, and RMPs to support regulatory submissions (IND/NDA/IRB).
- Led safety initiatives for multiple oncology programs, enhancing signal management, aggregate safety reports, and benefit–risk evaluations.
- Supported post-authorization safety activities, including PASS and risk minimization measures, to maintain patient safety and regulatory compliance.
- Partnered with clinical, regulatory, and quality teams to ensure inspection and audit readiness, facilitating compliance and operational integrity.
- Mentor junior PV scientists on safety data review, case processing, and compliance processes.
Pharmacovigilance Scientist
Mersana Therapeutics
Cambridge
06.2021 - 07.2023
- Managed safety data collection, review, and analysis for oncology clinical trials (ADC programs), ensuring data integrity and compliance.
- Collaborated on signal detection and medical review, identifying and assessing potential emerging risks to enhance patient safety.
- Strengthened PV system compliance and supported regulatory inspections and audits (FDA, EMA).
- Authored Safety Management Plans (SMPs) and DSURs, contributing to regulatory filings.
- Improved PV processes by developing new templates, training materials, and workflows, streamlining operations and facilitating team training.
Associate Pharmacovigilance Scientist
PDL Biopharma Inc.
Fremont
01.2015 - 05.2021
- Executed signal detection and trend analysis from safety database outputs to identify potential safety signals.
- Assisted in preparation of aggregate reports (PADERs, PSURs, DSURs) and performed literature surveillance to ensure compliance and patient safety.
- Managed ICSR processing, case medical review, and coding using MedDRA and WHO-DD.
- Participated in SOP revisions, Argus system upgrades, and developed training materials to enhance staff knowledge and operational efficiency.
Clinical Research Coordinator
University of Alabama
Birmingham
04.2012 - 11.2014
- Coordinated clinical data management, endpoint adjudication, and AE/SAE reporting for NIH-funded studies, ensuring data integrity and regulatory adherence.
- Monitored compliance with GCP and ICH guidelines across investigator-initiated trials, mitigating risks and enhancing study quality.
- Coordinated clinical trial activities and ensured compliance with regulatory standards.
- Managed participant recruitment and maintained accurate subject enrollment records.
- Collaborated with investigators to develop and implement study protocols.
Physician (Primary Care & Internal Medicine)
Hygiea Health Hospital & University of Benin Teaching Hospital
01.2007 - 01.2012
- Provided evidence-based clinical care in internal medicine and infectious diseases, ensuring optimal patient outcomes.
- Diagnosed patient conditions using comprehensive medical examinations and assessments.
- Developed treatment plans tailored to individual patient needs and health goals.
- Coordinated pharmacotherapy management and contributed to adverse drug reaction (ADR) reporting programs, enhancing patient safety.
- Collaborated with multidisciplinary teams to ensure cohesive patient care strategies.
Education
Ph.D. - Translational Science
University of Austin
Austin, Texas05-2026
Master of Public Health (MPH) - Public Health
University of Alabama
Birmingham12-2012
M.D. - Medicine
University of Benin
Nigeria06-2006
Skills
- Safety Surveillance & Signal Detection
- Case Processing & Medical Review
- Aggregate Safety Reports
- Benefit–Risk Evaluation & Risk Management
- PV Databases & Tools
- Regulatory Submissions
- Safety Governance
- SOPs
- CAPA Development
- Therapeutic Areas
Affiliations
- International Society of Pharmacovigilance (ISoP)
- Drug Information Association (DIA)
- Regulatory Affairs Professionals Society (RAPS)
- American Society of Hematology (ASH)
Certification
- Advanced Pharmacovigilance & Argus Safety
- Good Clinical Practice (GCP)
- Project Management Fundamentals
Timeline
Pharmacovigilance Scientist
IDRx Pharmaceuticals
12.2023 - Current
Pharmacovigilance Scientist
Mersana Therapeutics
06.2021 - 07.2023
Associate Pharmacovigilance Scientist
PDL Biopharma Inc.
01.2015 - 05.2021
Clinical Research Coordinator
University of Alabama
04.2012 - 11.2014
Physician (Primary Care & Internal Medicine)
Hygiea Health Hospital & University of Benin Teaching Hospital
01.2007 - 01.2012
Ph.D. - Translational Science
University of Austin
Master of Public Health (MPH) - Public Health
University of Alabama
M.D. - Medicine
University of Benin