Data Entry Drug Safety

DARIAN THERESSA HUNTER

***********@*****.*** 678-***-**** 2054 Kildaire Farm Rd. #346, Cary, NC 27518

A pharmacovigilance professional, with career expertise, guidance and assistance within pharmacovigilance (drug safety) and surveillance. Experienced regulatory affairs professional with over 18 years in the pharmaceutical industry. Proficient in navigating FDA regulations and adhering to ICH guidelines to ensure compliance and expedite product approvals. Extensive front-end user experience in safety platforms (AERS/ARGUS).

PROFESSIONAL EXPERIENCE

Sr. Clinical Safety Associate, CTI Clinical Trial and Consulting Services, Covington, KY 01/22 – 04/25

Monitor and maintain “Triage” inbox each day

Immediately assess all SAE reports for minimum case criteria and reportability

Independently take appropriate action to address cases without valid case criteria

Track all incoming SAEs; including duplicate checks and redaction as indicated

Coordinate case workflow daily

Generate case file and case file forms, and extract clinical source information as indicated

Distribute cases to CSS and perform data entry and action item entry in Argus safety database

Perform full data entry and action item entry into Argus safety database

Capture Monthly Safety Department Internal Meeting Minutes

Scheduling and coordinating monthly Safety Surveillance meeting, including independently procuring/generating and formatting listings, determining appropriate data columns to include, and responsibility for meeting agenda and project-specific Safety Signal and Risk Assessment Report

Track all expedited safety reports to appropriate regulatory authority(s), sites, and ethical committees

Generate and review various listings for internal or external requirements

Ensure safety issues are promptly communicated to appropriate team members and Sponsors

Assist with preparing for periodic internal reviews of safety systems, files, and study related documentation of all safety related projects in preparation for Agency or Sponsor audits

Drug Safety Associate, ICON (Formerly PRA Health Sciences) Raleigh, NC 06/21 – 09/21

Tracked entry of received ICSRs into company client safety database

Uploaded and submitted as well as management of eTMF3 for SAE and SUSAR Safety Reports

Uploaded and submitted as well as management of PhlexTMF for SAE and SUSAR Safety Reports

Reviewed and maintained SCT (Safety Case Tracker)

Reviewed and maintained SLTS (Safety Letter Tracking System)

Drug Safety Associate, PRA Health Sciences, Raleigh, NC 07/20 – 06/21

Tracked entry of received ICSRs into company or client safety database

Generated concise, accurate and well written case narratives

Performed consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database

Coded in assigned data fields adverse events using MedDRA and concomitant medications using WHO drug in accordance with company conventions

Processed and editing of follow-up information into Safety Case Tracker

Reviewed main tracker to attach follow-up source documentation after redaction for review

Attached follow-up source AE and source General to database

Drug Safety Coordinator, Grifols, Inc., Clayton, NC 02/12 – 06/20

Effectively conducted new case triage upon receipt. Authors case processing forms, and queries Oracle safety database for follow up or potential duplicate case data. Manages the Pharmacovigilance Daily Case Status Report log and monitors full cycle case processing.

Reviewed, prepared, and incorporated company narrative comments prior to Clinical and Post Marketing approval packet submittal to the Vice President of Global Pharmacovigilance (QPPV) for review/approval of non-serious and serious cases processed at the Clayton site.

Performed MedDRA structured event coding.

Provided administrative support to Pharmacovigilance and Regulatory managers, by handling a large variety of administrative tasks to include recording of meeting minutes. Offered real-time scheduling support by booking meetings via Microsoft Outlook and other intra office support platforms.

Assisted Drug safety scientist (DSS) with pre-development & post-marketing adverse event case processing. Processes and tracks all non-cases via implementation of paperless management logic.

Escalated problematic issues to Pharmacovigilance Operations Manager for timely remediation.

Drug Safety Coordinator, Ockham Development Group, Cary, NC 01/08 – 11/11

Enacted work-related duties as assigned under site-specific policies and procedures, Good Clinical Practice (GCP), International Council for Harmonization (ICH), and U.S. Food and Drug Administration (FDA) guidelines and regulations.

Received, triaged, reviewed, and processed Safety data from various sources on time and within quality standards.

Monitored the electronic Safety mailbox and electronic case receipt to ensure timely triage and assessment of Serious Adverse Event Reports and forwarded reports to Safety Associates.

Performed data entry for tracking and Safety databases, coded relevant medical terminology, and performed quality control of all SAE case closure via Microsoft Excel.

Contributed to the review and analysis of Serious Adverse Event information for completeness and accuracy as well as corresponded with reporters to gather supporting information/documentation as needed.

Tracked reportable cases and reported to regulatory authorities, institutional review boards, and Principal Investigators within timelines and in a format compatible to requirement.

Receptionist / Operator, CB Richard Ellis, Alpharetta, GA 01/07 – 01/08

Engaged in the manufacture and sale of automated equipment, medical supplies, energy, and automation, for a global leader in real estate services.

Interacted with customers in an environment of intensive client traffic.

Used clear and concise oral communication skills to respond to internal and external customers.

Distributed mail and assisted site visitors.

Estate Recovery / Casualty Processor, Public Consulting Group, Inc., Atlanta, GA 10/05 – 12/06

Facilitated processes of Medicaid expenditures recovery made on behalf of individuals who resided in nursing homes for the Commonwealth of Kentucky and State of Tennessee.

Authored letters to send to attorney or court-appointed Executor/Executrix to request appropriate documentation needed to start the recovery process.

Reviewed documentation and correspondence before processing estate recovery leads and requests for exemptions; archived all manual files.

Utilized the Case Management Tracking System (CMTS) database to enable tracking of recovery and casualty leads; reviewed the Medicaid Monitoring Information System (MMIS) database to verify recipient amounts.

Document Control Specialist, American Red Cross Biomedical Services, Atlanta, GA 05/01 – 10/05

Managed and coordinated control of regulated documents including routing and issuing master records.

Reviewed status of regulated documents to ensure all files were current.

Maintained official files of regulated documents consisting of current Bio Sciences Directives (BSD), Local Operating Procedures (LOP), Standard Operating Procedures (SOP), compliance statements, obsolete or modified documents, and other related information.

Utilized information technology skills to maintain document control databases for tracking regulated documents, and forms to ensure that all requested documents and forms were revised, amended, and made obsolete as appropriate.

Regulatory Compliance Specialist II, Red Cross Biomedical Services, Atlanta, GA 10/00 – 04/01

Established prior component status and monitored confirmatory test results to notify consignees of market withdrawal for repeat reactive screening tests.

Initiated telephone contact with consignee and conducted follow-up through written notification as appropriate.

Initiated retrieval based on post-donation information.

Generated and evaluated reports in the Donor Management Information System (DMIS) and Cryo Donor Information System (CDIS) or the legacy system to track component and donor history.

Regulatory Affairs Stability Supervisor, Mikart Pharmaceuticals, Inc., Atlanta, GA 07/96 – 09/00

Received two promotions based on outstanding performance and leadership skills.

Integrated Good Manufacturing Practices (GMPs) to processing label documents for onsite testing.

Reported to Director of Scientific Affairs, accountable for supervising four employees.

Authored Stability Protocols and Standard Operating Procedure (SOPs).

Processed packaging masters, and scheduled stability studies to directly facilitate stability testing.

EDUCATIONAL BACKGROUND

B.A.- Music, Savannah State University (Savannah, Georgia) 06/1983

Capstone Institute of Mortgage Finance (Atlanta, Georgia) 12/2004

CORE COMPETENCIES

Skills / Knowledge of:

Microsoft Office Suite (Word, Excel, Outlook, PowerPoint)

PhlexTMF

eTMF

SharePoint

Good Clinical Practice (GCP)

European Union (EU) Regulations

cGMP and Global Regulatory Agency directives

E-trials Electronic Data Capture (EDC)

MedDRA: Medical Dictionary for Regulatory Activities

Veeva/electronic document management system

Databases: ARGUS, and AERS

Stellent (Archiving/Records Management)

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