OLUFEMI OYENEYIN
Safety and Pharmacovigilance Specialist
Summary
Experienced Safety and Pharmacovigilance Specialist with 8 years of clinical and medical expertise
supporting clinical trials. Proficient in pharmacovigilance processes, data analysis, and peer training
with strong skills in SAS and Argus for reconciliation and line listing duties.
Overview
8
8
years of professional experience
Work History
Safety and Pharmacovigilance Specialist
Resources International
Bethesda, MD
12.2020 - Current
- Allergy and Infectious Diseases (DAIDS) member, Accelerating
- COVID-19 Therapeutic Interventions and Vaccines ACTIV-1, and National Cancer Institute (NCI) for ongoing studies
- Reviews data entries made by team members to ensure the accuracy and consistency of case workflows
- Facilitates and leads project meetings
- Prepares aggregate reports for several investigational products monthly and quarterly inArgus
- Safety Database for the Division of AIDS (DAIDS) and the NIH Vaccine Research Center (VRC)
- Runs case listings of studies and products from stored processes with SAS
- Performs initial and follow-up data entry for Adverse Events (AEs) and Serious Adverse
- Events (SAEs) in Argus Safety Database
- Performs case processing and Med QC of Adverse Events in Argus Safety and NCRMS
- DAERS
- Creates mapping documents for data entry in Argus
- Establishes and maintains relationships with vendors, businesses, and other stakeholders
- Engages in mentoring associates, planning daily workloads, and maintaining open communication with team members to maintain scheduled deadlines
- Maintains knowledge of case handling Standard Operating Procedures (SOP) in addition to
- FDA regulations
- Utilizes Spotfire metrics to track and investigate safety issues to meet compliance with applicable SOPs, guidelines, Clinical Material Transfer Agreements, and other regulatory requirements
- Aids with onboarding new team members by performing quality control on case processing
- Prepares case narratives according to the approved template
- Formulates queries to send to sites to obtain additional information on submitted cases
- Configures code lists, studies, products, and licenses in Argus Safety Database for various tenants
- Reconciles AEs/SAEs in the safety database and electronic data capture system
- Uploads documents into the SharePoint system for efficient record-keeping and backup as
Drug Safety Specialist
12.2016 - 11.2020
- Worked with Drug Safety Physicians to improve safety for surveillance of medical products, detection and assessment of risks, and proposing risk mitigation activities
- Case review, QC of safety data in ARGUS, performing literature search, and other safety- related tasks
- Reviewed relevant source documents for consistency and verification of adverse event data
- Evaluated cases for seriousness, expectedness, and relatedness according to the protocol, investigator brochure, and package insert
- Reviewed clinical study adverse events for accuracy, integrity, and consistency according to project-specific guidelines
- Performed triage and assigned priority to incoming events and classified them according to regulatory reporting
- Performed appropriate coding of all medical history, adverse events, drugs, indications, and laboratory tests according to the proper dictionary (MedDRA, CDD, WHO-DD) per Standard
- Operating Procedures
- Maintained a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations
- Reconciled AEs/SAEs in the safety database system and electronic data capture system
- Confirmed the presence of adequate information needed to perform case evaluations
- Prepared narratives according to the approved template
- Performed listedness assessments for adverse events as per documents like Investigational
- Brochure
- Conducted adequate follow-up by sending out queries to obtain additional information on cases
Education
Doctor of Medicine - undefined
All Saints University School of Medicine
2018
The Protection of Human Research Subjects – Good Clinical Practice CITI course 2020, 2022 The Protection of Human Research Subjects – Track 1 Biomedical CITI course. - undefined
2022
National Institutes of Health – Security Awareness - undefined
2023
Institutes of Health – Privacy - undefined
2023
Skills
- SKILLS AND SOFTWARE PROFICIENCIES
- Pharmacovigilance Databases:
- Argus Safety, NCRMS DAERS, Oracle AERS
- Office Software: Microsoft Office Suite (Excel, Word, PowerPoint, Outlook), Microsoft
- Teams, Google Workspace
- Document Management Systems: SharePoint, Documentum
- Data Analysis and Management Tools: SAS, SQL
- Signal Detection and Management Software: Spotfire
- Compliance and Regulatory Tools: MasterControl
- Programming Languages:
- Python, SQL
- Statistical and Data Visualization Tools: Power BI, Tableau
- Regulatory and Reporting Tools: FDA Adverse Event Reporting System (FAERS)
- MedWatch
- Clinical Data Management Systems: Medidata Rave
Work Preference
Work Type
Full TimeWork Location
RemoteTimeline
Safety and Pharmacovigilance Specialist
Resources International
12.2020 - Current
Drug Safety Specialist
12.2016 - 11.2020
Doctor of Medicine - undefined
All Saints University School of Medicine
The Protection of Human Research Subjects – Good Clinical Practice CITI course 2020, 2022 The Protection of Human Research Subjects – Track 1 Biomedical CITI course. - undefined
National Institutes of Health – Security Awareness - undefined
Institutes of Health – Privacy - undefined
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