Gloria Miles
Summary
Bilingual, pharmacovigilance professional seeking role to further career. Experience processing and managing safety cases. Manages highly confidential information with professionalism and integrity. Excellent time management skills.
Overview
7
7
years of professional experience
Work History
Senior Safety Assistant
ICON, Plc (previously PRA Health Sciences)
Charlottesville, Virginia
04.2022 - Current
- Collaborates with team members and clients in numerous clinical trails within 24 to 72 hour deadlines to ensure project deliverables are provided in a timely manner.
- Prepares 2-10 SAE notifications to clients daily
- Ensures timely filing of completed documents to TMF.
- Creates and sends new or reminder queries to sites.
- Continuously learns new software to ensure proper management of study and patient data, study site contacts, and filing of trial Master files.
- Receives, processes, and tracks email, phone, and fax communications / documents provided by trial sites. Redacts PHI as needed.
- Pulls and prepares eCRFs from RAVE system for distribution to study team.
- Updates clinical data tracking systems, such as safety letter tracking systems, safety case trackers, and internal worksheets.
- Provides access to client and trial staff within relevant systems to ensure they receive timely reports.
- Provides QC and review of study specific materials (such as DSURs)
- Creates and updates Safety and Pregnancy Reporting Documents.
- Sends safety submissions to regulatory authorities, as needed.
- Updates safety submission software to ensure timely submissions to site and non-site staff members.
- Manages TMF reconciliation efforts.
- Provides training to newly onboarding members.
Safety Assistant II
PRA Health Sciences
Charlottesville, Virginia
04.2021 - 03.2022
- Collaborates with team members and clients in numerous clinical trails within 24 to 72 hour deadlines to ensure project deliverables are provided in a timely manner.
- Creates and edits Safety Report Forms and Pregnancy Report Forms.
- Prepares 2-10 SAE notifications to clients a day.
- Creates and sends new queries and query reminders to sites.
- Ensures timely filing of completed documents to the TMF.
- Assists with TMF reconciliation efforts.
- Continuously learns new software to ensure proper management of study and patient data, study site contacts, and filing of trial Master files.
- Receives, processes, and tracks email, phone, and fax communications / documents provided by trial sites. Redacts PHI as needed.
- Pulls and prepares eCRFs from RAVE system for distribution to study team.
- Updates clinical data tracking systems, such as safety letter tracking systems, safety case trackers, and internal worksheets.
- Updates safety reporting software to ensure timely submissions of safety reports to sites and non-site staff members.
- Performs QC and reviews of written study materials (such as DSURs).
- Assists training of newly onboarded safety assistants.
Safety Assistant I
PRA Health Sciences
Charlottesville , VA
06.2020 - 03.2021
- Collaborates with team members and clients in numerous clinical trails within 24 to 48 hour deadlines to ensure project deliverables are provided in a timely manner.
- Creates and edits study report forms.
- Prepares 2-10 SAE notifications to clients a day.
- Ensures timely filing of completed documents to the TMF.
- Continuously learns new software to ensure proper management of study and patient data, study site contacts, and filing of trial Master files.
- Receives, processes, and tracks email, phone, and fax communications / documents provided by trial sites. Redacts PHI as needed.
- Updates clinical data tracking systems, such as safety letter tracking systems, safety case trackers, and internal worksheets.
- Provides access to client and trial staff within relevant systems to ensure they receive timely reports.
Referral Coordinator
GoochlandCares
Goochland, VA
11.2019 - Current
- Developed and maintained databases to track Medicaid Application Program, Referral Program, and Wellness Program.
- Interviewed, screened, and managed laboratory interns and volunteers.
- Collaborated with private and nonprofit organizations to ensure seamless patient care to undeserved communities.
- Collected data and stories for donation groups and grant funding.
Patient Care Coordinator
Virginia League For Planned Parenthood
Richmond, Virginia
09.2017 - 03.2020
- Acted as main point of contact for patients, doctors and clinic staff by closely reviewing medical charts and maintaining high levels of communication.
- Wrote audit / improvement report to leadership with process improvement suggestions, resulting in overall 27% reduction in errors.
- Developed, wrote, and managed Patient Care Coordinator training program for new hires.
- Measured effectiveness with team and implemented recommendations for long term improvements.
- Coordinated charitable, government and community resources for patients.
Education
Master of Arts - Business Administration - Healthcare
Saint Leo University
Saint Leo, FL03.2021
Skills
- Microsoft Office Suite
- Multidisciplinary team collaboration
- Audit and Quality Control Assistance
- Clinical Trials
- RAVE, TMF, SharePoint
- Fluent in Spanish
Timeline
Senior Safety Assistant
ICON, Plc (previously PRA Health Sciences)
04.2022 - Current
Safety Assistant II
PRA Health Sciences
04.2021 - 03.2022
Safety Assistant I
PRA Health Sciences
06.2020 - 03.2021
Referral Coordinator
GoochlandCares
11.2019 - Current
Patient Care Coordinator
Virginia League For Planned Parenthood
09.2017 - 03.2020
Master of Arts - Business Administration - Healthcare
Saint Leo University
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