Amber Brown
Wilmington,NC
Summary
Registered Nurse with extensive experience in hospital nursing and most recently drug safety/pharmacovigilance, including post marketing and clinical trial serious adverse event reporting (device and drug studies), regulatory submissions, project set up/closure and all study lead activities.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Safety Specialist/Senior Safety Specialist
Rho, Inc.
Durham, NC
12.2023 - Current
- Leads multiple, high-volume clinical trial studies effectively
- Prepares safety related documents for assigned projects including safety management plans and site training materials.
- Performs safety training for sites with internal and external team.
- Supports and mentors new employees on all aspects of pharmacovigilance.
- Collaborates with the internal project team and the sponsor to determine the scope and specifics of safety data collection, processing, and reporting for assigned projects.
- Involved in start-up of new studies and closeout of completed studies.
- Performs initial assessment of all safety reports for potential expedited reporting to the FDA or other applicable health authorities.
- Coordinates and performs adverse event data entry, narrative writing, coding/coding review, case quality control review, follow-up, tracking of reports, and regulatory reporting activities.
- Effectively maintain the safety database and corresponding entry guidelines, including accuracy of data and assurance of quality of data.
- Responsible for performing reconciliation between the clinical and safety database.
- Actively involved in internal and external team meetings to support project management team representatives with pharmacovigilance input.
- Facilitates communication between project team members and site staff.
- Works independently to organize workload to comply with deadlines and priorities.
- Enters queries in clinical database and works with clinical sites for quality of information necessary for SAE reporting.
- Provides comprehensive support to the Product Safety department with special projects and process development.
Senior Safety Specialist
IQVIA Biotech
Durham, NC
09.2021 - 12.2023
- Delivered Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.
- Primary responsibilities included processing and reporting of incoming safety events and related data for device and drug clinical trials.
- Performed safety case processing tasks including, but not limited to: Intake and triage tasks as applicable for assigned projects, reviewing incoming safety information for completeness and accuracy Tracking and data entry, writing clinical narratives, generating queries, contacting sites for missing and/or unclear information, qc of cases and provide feedback as appropriate, and generating regulatory reports.
- Mentored and trained new Safety Specialists and QC of tests cases.
- Lead/Back-up lead for device studies and all applicable tasks, including study start up and closure, SAE/AE reconciliation.
- Back-up lead for combination Drug/Device studies.
- Lead device QC monthly forum.
- Safety Reporting tasks and required submissions per regulatory authorities.
Safety Specialist
IQVIA Biotech
Durham, NC
11.2019 - 09.2021
- Delivered Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.
- Primary responsibilities included processing and reporting of incoming safety events and related data.
- Performed safety case processing tasks including, but not limited to: Intake and triage tasks as applicable for assigned projects, reviewing incoming safety information for completeness and accuracy, tracking and data entry, writing clinical narratives, generating queries, contacting sites for missing and/or unclear information, qc of cases and provide feedback as appropriate, and generating regulatory reports.
- Safety Reporting tasks and required submissions per regulatory authorities.
Safety Specialist
PPD
Wilmington, NC
10.2017 - 11.2019
- Responsible for processing Serious Adverse Event (SAE) for Clinical Trial Studies, which included triage, review, safety database entry, tracking, narrative writing, requesting follow-up from reporter and reporting to client(s) or agencies for assigned projects.
- Responsible for adhering to PPD's corporate policies, SOPs/WPDs, and awareness of ICH GCP guidelines and other relevant global and local regulations.
- Effectively interfaced with Project Teams regarding SAE activities.
- General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required for processing SAEs.
- Ensured any expedited safety reports were submitted to applicable Regulatory Authorities, Ethics Committees and Principal Investigators within regulatory timelines.
- Coordinated and performed adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database, review of cases for quality, consistency and accuracy, followed up with reporter and/or associated HCP, tracked reports, and reporting activities.
- Coded adverse event terms and wrote narratives according to client convention.
- Maintained knowledge and understanding of PPD and client-provided SOPs and current local and global regulations.
- Effectively communicated with core processing team members and client facing team members.
Registered Nurse
Wake Medical Center
03.2012 - 02.2018
- Medical-surgical experience on an observation unit caring for various types of observation status patients, then continued to an orthopedic/oncology unit to care for post-surgery and cancer patients.
Registered Nurse
Federal Medical Center
06.2006 - 04.2012
- Medical-surgical experience on an inpatient hospital unit treating acute and chronic disease patients.
Education
Associate in Applied Science - Nursing
Vance Granville Community College
01-2006
Skills
Transplant
Oncology
Cardiovascular
Respiratory
Dermatology
Allergy/Asthma
Autoimmune Disease
Certification
2006 to Present- Registered Nurse Licensure in state of NC
Timeline
Safety Specialist/Senior Safety Specialist
Rho, Inc.
12.2023 - Current
Senior Safety Specialist
IQVIA Biotech
09.2021 - 12.2023
Safety Specialist
IQVIA Biotech
11.2019 - 09.2021
Safety Specialist
PPD
10.2017 - 11.2019
Registered Nurse
Wake Medical Center
03.2012 - 02.2018
Registered Nurse
Federal Medical Center
06.2006 - 04.2012
Associate in Applied Science - Nursing
Vance Granville Community College