Argus Safety
Lauren Goss
Drug Safety Specialist
Clarksville,TN
Summary
Logical and dedicated pharmacovigilance professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure, solving problems, and adapting to new situations and challenges to deliver tangible and quantitative results while focusing on quality care.
Overview
6
6
years of professional experience
5
5
years of post-secondary education
Work History
Drug Safety Specialist
ICON Plc. (Gilead Sciences - Contractor)
Brentwood, TN
03.2021 - 10.2022
- Navigated intricacies of drug safety databases to process adverse event reports while meeting compliance requirements and determining prioritization of cases received.
- Reviewed and triaged clinical trial deaths and adverse events including serious adverse events.
- Interacted with project manager to discuss ongoing projects and maintain workflow and timelines while meeting compliance.
- Supported audit procedures to check all procedures, processes and work standards.
- Ensured consistency in the evaluation, recording and coding (MedDRA and Who-Drug) of serious adverse event and adverse events.
- Compared adverse event source documents against safety database screens for transcription and medical accuracy.
- Maintained awareness of performance metrics to remain within established limits.
- Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
- Gathered and evaluated quality assurance data to identify issues and improve process efficiency.
- Monitored and reviewed serious adverse event queries and sent to investigator sites and CRAs as follow up query primary while utilizing query templates and actively tracking within Argus Safety and Spotfire.
- Forwarded emails to relevant stakeholders and ensured timely escalation of urgent communications
Pharmacy Assistant
Hermitage Pharmacy
Nashville, TN
11.2020 - 03.2021
- Communicated instructions to patients or caregivers about proper use and storage of drugs.
- Performed safety checks when dispensing medications to optimize patient safety.
- Processed incoming drug orders by checking deliveries against paperwork and updating computer system.
- Trained new pharmacy staff on computer system and drug management protocols.
- Assisted in the writing and revision of Standard Work Procedures along with SOPs (standard operating procedure).
- Organized, planned, and prioritized work to ensure completion by a given deadline.
Treatment Coordinator
Pacific Dental Services
Clarksville, TN
09.2019 - 07.2020
- Performed in team leader capacity and organized all treatment and placement activities.
- Reviewed each step of patient care and made proactive adjustments to avert issues.
- Established rapport and relationships with patients and external partners to cross-train and support medical staff.
- Educated patients on dental benefits and coordinated proper payment with insurance companies.
- Researched billing issues and verified insurance coverage.
- Made analytical decisions with little to no input from management.
Surgery Coordinator
Saint Thomas Surgery Center - Midtown
Nashville, TN
09.2016 - 05.2019
- Served as oversight team lead for any and all surgery scheduling sent to surgery facility.
- Expertly managed planning, scheduling and coordination of outpatient procedures.
- Reviewed medical histories and current information to provide accurate information to surgeons.
- Documented and collected patient data to maintain accuracy and security.
- Maintained efficient surgery schedule by monitoring daily activities and resolving potential conflicts.
- Fostered collaborative relationships among health care team by communicating, responding to requests and building rapport.
- Contacted hospitals to confirm patients medical histories and prevent inaccurate diagnoses and treatments.
- Trained new hires and current employees from other functional areas on a new software system called CaseTabs.
Patient Access Representative
Tennessee Orthopaedic Alliance
Nashville, TN
01.2016 - 09.2016
- Determined patient financial needs and referred eligible patients to proper county, state or federal agencies to obtain financial assistance.
- Resolved patient financial problems with guidance from documented guidelines and procedures.
- Assisted the office manager on a daily basis with financial budgets and company goals.
- Offered simple, clear explanations to help clients and families understand hospital policies and procedures.
Education
Bachelor of Science - Behavioral & Health Science
Austin Peay State University
Clarksville, TN 08.2010 - 05.2015
Skills
Training and mentoring
Adverse Event Reporting
MedDRA Coding
Regulatory Compliance
Data Analysis
GCP & ICH guidlines
GXP Knowledge
Clinical Trials
Medical Terminology
Stakeholder Engagment
Planning and Coordination
Workflow Management
Additional Information
- Inspire Award, ICON plc - February 2022
Software
Spotfire
Microsoft Office (Advanced Excel, PowerPoint, & Word)
Microsoft SharePoint
Electronic Data Capture (EDC)
GLASS (Drug Safety Triager)
Adobe Pro
Sparc
Veeva Vault
Clinical Trial Management System (CTMS)
Google Drive
Timeline
Drug Safety Specialist
ICON Plc. (Gilead Sciences - Contractor)
03.2021 - 10.2022
Pharmacy Assistant
Hermitage Pharmacy
11.2020 - 03.2021
Treatment Coordinator
Pacific Dental Services
09.2019 - 07.2020
Surgery Coordinator
Saint Thomas Surgery Center - Midtown
09.2016 - 05.2019
Patient Access Representative
Tennessee Orthopaedic Alliance
01.2016 - 09.2016
Bachelor of Science - Behavioral & Health Science
Austin Peay State University
08.2010 - 05.2015