Linda Ogwuazor
Kensington
Summary
Detail-oriented and results-driven Safety Scientist with 4 years of experience in drug safety surveillance and post-marketing safety evaluation. Proven expertise in signal detection and validation, comprehensive literature review, and authoring of aggregate safety reports including PADERs, DSURs, and PSURs. Skilled in analyzing safety data to support regulatory submissions and benefit-risk assessments. Adept at cross-functional collaboration and committed to ensuring patient safety through rigorous pharmacovigilance practices.
Overview
11
11
years of professional experience
Work History
Global Medical Safety Associate
Otsuka Pharmaceuticals
07.2021 - Current
- Led the development and submission of the PADER and ensured accurate data compilation, analysis, and timely submission in compliance with regulatory requirements
- Reviewed and analyzed safety data using electronic document monitoring systems such as ARGUS, CREDO, and Empirica signal/FAERS
- Utilized graphics and statistical software such as Power BI to analyze and present data.
- Ensured patient safety for company products and maintained compliance with the pharmacovigilance regulations of regulatory agencies around the globe through the application of health authority guidelines
- Continuously assessed the benefit/risk ratio of oncology products during their lifecycles through signaling activities
- Conducted analysis of scientific literature to detect new safety information and potential signals
- Successfully coordinated cross-functional teams to gather necessary information, identify key trends, and ensure report quality, contributing to the company's adherence to industry standards and regulatory timelines.
- Presented in safety governance meetings
- Authored comprehensive narratives and key sections for aggregate reports including the PADER and PSUR
- Managed the end-to-end process of gathering, reviewing, and presenting patient exposure data, ensuring accuracy and completeness for reporting purposes in documents such as the NDA, PSUR, and DSUR
- Updated the Risk Management Plan for company products
- Updated a company Core Safety Risk Document
Pharmacy Intern
Walgreens
11.2016 - 07.2021
- Enhanced interprofessional relations between physicians, payers, and the pharmacy by serving as a liaison in processing third-party payer claims; resolved 80 billing issues on a weekly basis
- Improved patient outcomes and adherence by counseling patients on medication inquiries at point of sale transactions
- Accelerated pharmacy operations by mentoring and training incoming personnel to ensure timely completion of daily technician tasks
- Managed purchasing activities by ordering pharmaceutical products through affiliate vendor, AmerisourceBergen
- Facilitated internal monthly audits to maintain inventory and reach designated goals
Office of Program and Regulatory Operations Extern
Food and Drug Administration (FDA)
09.2020 - 10.2020
- Assessed Abbreviated New Drug Applications (ANDAs) alongside Regulatory Business Process Managers (RBPM) to ensure project deadlines are met by Generic Drug User Fee Amendment (GDUFA) standards
- Archived Drug product reviews, quality amendments, and Drug Master Files for major/minor deficiencies to provide feedback to sponsors in a timely manner.
- Created updated review documents for the RBPM on GDUFA I and II standards
- Preceptor: Dr. Selamawit Hailu
Global Education and Awareness Researcher
Chulalongkorn University
06.2014 - 07.2014
- Studied the effects of Avicequinone C derivatives on dihydrotestosterone production in human hair dermal papilla cells
- Assisted in the preliminary stages of the drug development process for premature balding treatment in the Department of Pharmacology
- Designed and presented a poster at the Emerging Researchers National Conference and Howard University Research Day 2015
- Supervising Faculty: Dr. Wanchi De’Eknamkul, PhD
Education
Doctor of Pharmacy - undefined
Howard University College of Pharmacy
05.2021
Bachelor of Science - Biology
Howard University
05.2016
Skills
- Argus
- CREDO
- PowerBI
- Microsoft Excel
- MedDRA
- Signal detection proficiency
- Teamwork and collaboration
- Time management
- Attention to detail
- Critical thinking
Awards
Edmund & M. Pioleau Scholarship Recipient August 2019, NIH Endowment Grant Recipient August 2017, Founder’s Scholar August 2012 – May 2016, National Achievement Scholarship Finalist January 2011 – December 2012
Affiliations
- American Pharmacists Association (APhA) Fall 2017 – current
- Industry Pharmacists Organization (IPhO) Fall 2017 – current
- Capitol City Pharmacy Medical Reserve Corps (CCPMRC) Fall 2017 – current
Publications
- Ogwuazor LI, Hailemeskel B, and Abebe, M. (2020). The Repercussions of Self-Medication in Africa and Best Practices for Developing Nations. Educ Res Appl 5: 170. DOI: 10.29011/2575-7032.100170
- Ogwuazor, Linda, De-Eknamkul, W, “Testing Possible Treatments for Androgenic Alopecia in Cell-Based Assay Systems,” Emerging Researchers National Conference: February 2015
Timeline
Global Medical Safety Associate
Otsuka Pharmaceuticals
07.2021 - Current
Office of Program and Regulatory Operations Extern
Food and Drug Administration (FDA)
09.2020 - 10.2020
Pharmacy Intern
Walgreens
11.2016 - 07.2021
Global Education and Awareness Researcher
Chulalongkorn University
06.2014 - 07.2014
Doctor of Pharmacy - undefined
Howard University College of Pharmacy
Bachelor of Science - Biology
Howard University
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