Sakeena Frye
Wendell,United States
Summary
Experienced clinical professional with a strong track record in
ensuring data integrity, regulatory compliance, and adherence
to Good Clinical Practice (GCP) standards. A meticulous focus
on data quality and patient safety. Proficient in protocol adherence, risk assessment, and protocol deviation management. Excellent communication and relationship-building skills.
Overview
8
8
years of professional experience
Work History
Safety Reporting Coordinator
IQVIA
11.2019 - Current
- Perform intake and triage of incoming safety events and related data.
- Monitor safety email inbox, safety fax, and SAE hotline for incoming reports.
- Identify and blind patient identifiers in accordance with privacy regulations.
- Identify relevant studies and events, distinguishing new information from follow-up reports.
- Create and maintain case files for safety events.
- Complete tracking of incoming safety-related documents.
- Initiate data entry into safety databases and ensure accuracy.
- Maintain project-specific tracking tools to monitor case status.
- Prepare safety submission packages for Quality Control and TMF upload.
- Assist in preparing safety reports for submission to Sponsors and Regulatory Authority.
- Manage reporting of protocol deviations and drive timely query resolution.
- Support audit readiness standards and prepare for audits.
- Collaborate with cross-functional teams and ensure effective communication.
Principal Safety Reporting Administrator
PPD
08.2018 - 11.2019
- Successfully submitted safety reports to relevant parties, ensuring compliance with SOPs and WPDs
- Efficiently resolved complex issues related to submission packs, collaborating with Safety Specialists and
- Reporting Specialists
- Assisted in receiving and preparing safety report submissions, including log sheet entry, cover letter and third-party email preparation
- Provided leadership and guidance to team members, establishing effective communication with relevant departments
- Supported audit readiness activities, developed training materials, organized meetings, and maintained accurate records
- Extracted and compiled reporting information using the Clinical Trial Management System, updated contact lists, and troubleshooted arising issues
- Conducted training sessions on Safety Reporting procedures and PPD system updates for Pharmacovigilance staff
- Provided filing support for multiple projects, ensuring accurate barcoding, identification of problems, and maintaining a well-organized file room.
Safety Reporting Specialist
PPD
01.2018 - 08.2018
- Received, prepared, and submitted safety reports to relevant parties, ensuring compliance with regulatory timelines and country legislation
- Escalated any issues to lead and/or line manager
- Assisted in generating metrics and promptly alerted manager of any quality or timeline concerns
- Participated in project teams and occasionally took the lead on small to moderate scope projects
- Provided training and support to team members.
- Performed administrative task such as filing and maintaining safety reporting systems and information.
- Collaborated with various departments to facilitate safety reporting task and the establishment of client accounts.
Country Approval Specialist
PPD
05.2016 - 01.2018
- Prepared, reviewed, and coordinated local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy, under guidance
- Provided local regulatory strategy advice (MoH & EC) to internal clients, under guidance
- Provided project specific local Site Intelligence and Activation (SIA) services and coordinated these projects
- Served as the key contact at the country level for either Ethical or Regulatory submission-related activities
- Coordinated with internal functional departments to ensure alignment of various site start-up activities with submissions activities and mutually agreed upon timelines
- Worked with start-up CRA(s) to prepare regulatory compliance review packages, as applicable
- Developed country-specific Patient Information Sheet/Informed Consent form documents
- Assisted with grant budgets and payment schedules negotiations with sites
- Supported the coordination of feasibility activities in accordance with agreed timelines
- Entered and maintained trial status information relating to Site Intelligence and Activation (SIA) activities onto PPD tracking databases accurately and timely
- Ensured the preparation, set up, and maintenance of local country study files and filing processes as per PPD
- WPDs or applicable client SOPs
- Maintained knowledge of and understood PPD SOPs, Client SOPs/directives, and current regulatory guidelines applicable to services provided.
Clinical Trials Assistant
Quintiles/Contractor
08.2015 - 04.2016
Education
Bachelor of Science - Healthcare Administration
North Carolina Wesleyan College
Rocky Mount, NC12.2024
Associate of Arts - Healthcare Administration
University of Phoenix
Tempe, AZ10.2011
Skills
- Clinical Trial Management System (CTMS) knowledge
- Regulatory documentation expertise
- Ethics documentation expertise
- Regulatory authority interaction skills
- IEC/IRB interaction skills
- Site contract and budget negotiation skills
- Translation management skills
- Site communication skills
- Local regulation knowledge
- Essential Document Package preparation skills
- Attention to detail and accuracy
- Ability to manage multiple projects simultaneously
Timeline
Safety Reporting Coordinator
IQVIA
11.2019 - Current
Principal Safety Reporting Administrator
PPD
08.2018 - 11.2019
Safety Reporting Specialist
PPD
01.2018 - 08.2018
Country Approval Specialist
PPD
05.2016 - 01.2018
Clinical Trials Assistant
Quintiles/Contractor
08.2015 - 04.2016
Bachelor of Science - Healthcare Administration
North Carolina Wesleyan College
Associate of Arts - Healthcare Administration
University of Phoenix
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