Summary
Overview
Work History
Education
Skills
Research And Publications
Languages
Timeline
Generic

Sunday Nnadozie

Lewisville,TX

Summary

Logical DRUG SAFETY/Pharmacovigilance Specialist with background identifying, assessing and preventing adverse effects or medications, vaccines and related pharmaceutical items. Dedicated expert with focus on maintaining drug safety by preparing and reviewing data and reports. Meticulous when authoring professional documents and reviewing scientific literature.

Overview

8
8
years of professional experience

Work History

CLINICAL DRUG SAFETY/Pharmacovigilance Specialist

IQVIA
12.2022 - 04.2024
  • Review the safety reporting section of protocols
  • Develop and maintenance the SAE form for studies
  • Develop and maintenance the Safety Management plan
  • Support the eTMF safety sections
  • Attend cross-functional study program meetings
  • Support the Investigator meetings on topics such as the Study SAE reporting
  • Oversee PV vendors activities:
  • Run Argus reports (master Line Listing, open activities, submissions records)
  • Receipt of SUSAR, SAE, AESI, process, review of SUSARs, quality check, support unblinding process, and distribution to regulatory authorities
  • Manage ongoing training needs to PV Vendor
  • Manage the SAE reconciliation process for all assigned programs monthly ensuring discrepancies are resolved
  • Collaborate with PV compliance and governance on quality events relating to Clinical Safety Operations.
  • Participate in process improvement projects
  • Supports local inspection readiness in line with global PV strategy
  • Identify issues and raise them to help Horizon be inspection ready and compliant.
  • Archive documents per applicable internal standards and operating procedures
  • Support global medical review of pharmaceutical technical complaints and medical information inquiries were applicable
  • Assist in MedDRA coding of medical terms for clinical study reports
  • Support local PV relevant projects and document review
  • Collaborate to monitor the Clinical Safety Operations electronic mailbox
  • Responsible for supporting the accurate and timely collection, assessment and reporting of adverse events reported in associated with CTI commercial or investigational medicinal product.
  • Compile aggregated safety reports (e.g., PSUR, DSUR, PADR or equivalent), clinical section of licensing renewal submissions
  • Review and provide input to the safety sections of protocols and the risk section of informed consent documents.
  • Support and inform Reference Safety Information update (e.g., SmPC, IB and/or Core Safety Data Sheet)
  • Review and assessment of published literature for AEs associated with CTI product. May review draft CTI publications for accuracy.
  • Assist in implementation of compliance standards and review compliance metrics for risk and/or corrective action
  • Assist in developing and updating processes and procedures related to safety data collection, aggregation, analysis and reporting
  • Inform and support the validation of PV data systems.
  • Assign correct standardized medical coding nomenclature to reported terms (MedDRA and/or WHO Drug Dictionary)
  • Inform company coding guidelines and participate in coding review/reconciliation between safety database and clinical database(s) as applicable.
  • Assist in the creation of PV training plans and support the execution of those plans within CTI and external to CTI
  • Assist in the oversite, guide and assess the quality of vendors supporting PV operations
  • PV team tasks:
  • Manage and maintain Spark PV mailbox.
  • Track daily ICSR incoming cases
  • Track Aggregate Report
  • Track SAE reconciliation
  • Organize and write meeting minutes for PV team meetings and other meetings if needed
  • Vendor management support:
  • Support vendor oversight of all case intake and processing activities:
  • Case review
  • Escalation of case level issues when necessary
  • Support convention-related training delivery to vendor
  • Support any queries on Intake, triage and data entry of ICSRs by vendor
  • Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
  • Ensuring that ICSRs and other safety related documents are exchanged within time frames agreed by Pharmacovigilance Safety Agreement
  • SAE Reconciliation:
  • Support PV Ops Lead in overseeing PV vendor on Serious Adverse Event (SAE) Reconciliation activities with the SAE information in the clinical trial database.
  • Liaise between clinical team or their CROs and the PV vendor to resolve any issues from the SAE reconciliation
  • Clinical safety:
  • Represent PV to attend clinical meetings and manage clinical safety issues in the absence of PV Ops Lead.
  • Aggregate reporting:
  • Support and assist PV Patient Safety Lead team for the preparation of DSUR/PBRER (PSUR) by delivering required documents or listings from the vendor.

Clinical Research Coordinator

CARE ACCESS
12.2019 - 11.2021
  • Serve as a primary contact to ensure appropriate communications, trial management and coordinates the operational aspect of an on-going clinical trial at site, Monitored activities at clinical study sites to ensure adherence to Good Clinical Practice (GCP) guidelines,
  • Leads in recruitment of study subjects
  • Aides in accessing eligibility of patients for participation in protocols
  • Participates in the administration of informed consent process
  • Responsible for the collection, entering and maintenance of data
  • Reviews data and progress notes with CRC's principal investigator
  • · Prepares study files for data
  • · Prepares lab kits for upcoming research visit
  • · Processes blood and urine samples for shipping
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Followed informed consent processes and maintained records.
  • Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
  • Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
  • Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.

Medical Administrative Assistant (120-hour internship for healthcare program)

A Given Heart Home Agency
03.2021 - 04.2021
  • Collaborated with the supervisor and preceptor in providing utmost care and patient monitoring by utilizing health chart reports and updating the patient records
  • Supervised care givers by training them with patient care ethics, ensuring the continuity of the personalized care given to each patient.
  • Handled sensitive patient information with discretion, adhering to strict HIPAA guidelines and safeguarding privacy at all times.
  • Organized paperwork such as charts and reports for office and patient needs.
  • Provided exceptional customer service to patients, addressing concerns promptly and professionally to ensure satisfaction.
  • Answered incoming calls, routed messages and resolved patient inquiries within target timeframes.

Clinical Research Site Initiation Assistant

Eli Lilly Pharmaceuticals
10.2017 - 07.2019
  • Assisted in a research study by collecting information and samples such as blood, water, soil, plants and animals for research data analysis
  • Monitored and observed experiments, recording production and test data for evaluation
  • Analyzed experimental data and interpreted results to write reports and summaries of findings.
  • Contributed to a positive work environment with strong interpersonal skills and proactive teamwork attitude.
  • Greeted guests in with friendliness and professionalism.
  • Answered incoming phone calls to process requests, transfer calls, or relay messages to appropriate personnel.
  • Worked closely with management to provide effective assistance for specific aspects of business operations.
  • Assisted manager in all aspects of business operations.
  • Monitored and ordered supplies and materials to keep office well stocked.

Surgical Intern

Boryspil Emergency Hospital (Surgery Department)
07.2016 - 09.2016
  • Assisted in general surgical procedures leading to a successful procedure on every patient and gained knowledge on extensive surgical procedures
  • Performed internal medicine clerkship by ensuring the proper patient documentation are communicated to all departments involved.

Education

Doctor of Medicine in Medicine -

Lugansk State Medical University
Lugansk, Ukraine
06.2012

Skills

  • Microsoft Office Suite (MS Word, Excel, PowerPoint), CareSmartz360, Electronic Medical Record (EMR)
  • Case Processing
  • Adverse event reporting
  • Post-marketing surveillance
  • Drug Safety Monitoring
  • Signal detection
  • Pharmacokinetics Knowledge
  • Pharmacovigilance Regulations
  • Pharmacodynamics Understanding
  • MedDRA Coding
  • Safety Compliance
  • Functional Testing
  • Data Entry

Research And Publications

  • Surgical treatment of ulcers: Current and future practices. (Co-author)
  • Oncological pain and the stressful sequel affecting quality of life in an uncertain world: A narrative review. (Co-author)

Languages

Russian
Limited Working

Timeline

CLINICAL DRUG SAFETY/Pharmacovigilance Specialist

IQVIA
12.2022 - 04.2024

Medical Administrative Assistant (120-hour internship for healthcare program)

A Given Heart Home Agency
03.2021 - 04.2021

Clinical Research Coordinator

CARE ACCESS
12.2019 - 11.2021

Clinical Research Site Initiation Assistant

Eli Lilly Pharmaceuticals
10.2017 - 07.2019

Surgical Intern

Boryspil Emergency Hospital (Surgery Department)
07.2016 - 09.2016

Doctor of Medicine in Medicine -

Lugansk State Medical University

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Sunday Nnadozie