Yvonne Obanya
Dallas,Texas
Summary
Experienced Senior Safety Scientist and High-performing professional with extensive experience in industry. Skilled in testing, sorting and sampling products with working knowledge of safety codes, seeking opportunities to drive signal detection, aggregate report compilation, and safety surveillance activities to ensure the safety and efficacy of pharmaceutical products across clinical and post-marketing settings. Reliable and efficient with equipment and software programs.
Overview
5
5
years of professional experience
Work History
Safety Scientist
Willis Knighton Medical Center
11.2023 - Current
- Worked closely with Safety Physicians to drive signal detection and compile/analyze aggregate reports for assigned products
- Acted as an author for aggregate reports, including DSUR, PBRER, PSUR, and IB, and led the drafting process when required
- Contributed valuable insights as a member of the Safety Review Team, assessing safety data and informing risk management strategies
- Conducted routine and ad hoc safety surveillance activities, such as signal detection and literature review, for multiple programs
- Participated in and contributed to responses to health authorities, ensuring compliance with regulatory standards
- Supported the Head of Safety in conducting and documenting Safety Management Team meetings, ensuring effective communication and decision-making
- Reviewed and provided input on protocols, statistical analysis plans, and other clinical study-related documents to ensure alignment with safety objectives
- Developed and updated Safety Management Plans and Risk Management Plans to address evolving safety considerations
- Provided mentorship and guidance to junior Senior Safety Scientists, emphasizing post-marketing activities and professional growth within the DSPV team.
PV Safety Scientist
Christus Health
09.2021 - 11.2023
- Collaborated closely with Safety Physicians to drive signal detection and compile/analyze aggregate reports for assigned products
- Authored aggregate reports, including DSUR, PBRER, PSUR, and IB, and took the lead in drafting when necessary
- Played a pivotal role in the Safety Review Team, assessing safety data for signals and contributing to risk management decisions
- Conducted routine and ad hoc safety surveillance activities, such as signal detection and literature review, for various programs
- Participated in and supported responses to health authorities, ensuring timely and comprehensive submissions
- Assisted the Head of Safety in conducting and documenting Safety Management Team meetings, ensuring alignment with company objectives
- Provided input and review of protocols, statistical analysis plans, and other clinical study-related documents
- Developed and updated Safety Management Plans and Risk Management Plans as needed to address emerging safety concerns
- Offered mentorship and guidance to junior Senior Safety Scientists, fostering their professional development within the DSPV team.
Drug Safety Officer/Pharmacovigilance Scientist
Nuance Communications
05.2019 - 08.2021
- Collaborated with Safety Physicians to drive signal detection and compile/analyze aggregate reports for assigned products
- Contributed as an author to aggregate reports, including DSUR, PBRER, PSUR, and IB, and led the drafting of aggregate reports when required
- Served as a key member of the Safety Review Team, assessing safety data for signals and risk management strategies
- Conducted routine and ad hoc safety surveillance activities, including signal detection, literature review, and risk management for multiple programs
- Participated in and prepared responses to health authorities, ensuring compliance with regulatory requirements
- Supported the Head of Safety in conducting and documenting Safety Management Team meetings
- Reviewed and provided input on protocols, statistical analysis plans, and other clinical study-related documents
- Updated or developed Safety Management Plans and Risk Management Plans as needed to ensure product safety compliance
- Provided mentorship and guidance to junior Senior Safety Scientists within the DSPV team, focusing on post-marketing activities.
- Conducted thorough investigations into reported adverse reactions, identifying root causes and implementing corrective actions.
- Supported the development and implementation of effective risk mitigation strategies by providing timely and accurate drug safety data analysis.
Education
Bachelor of Science - Business Administration
Babcock University
Skills
- Signal Detection
- Aggregate Report Compilation
- Safety Surveillance
- Regulatory Compliance
- Risk Management
- Clinical Study Review
- Mentorship and Guidance
- Cross-functional Collaboration
- Pharmacovigilance Database Management
- Regulatory Agency Interaction
References
Available upon request
Timeline
Safety Scientist
Willis Knighton Medical Center
11.2023 - Current
PV Safety Scientist
Christus Health
09.2021 - 11.2023
Drug Safety Officer/Pharmacovigilance Scientist
Nuance Communications
05.2019 - 08.2021
Bachelor of Science - Business Administration
Babcock University
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