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Drug Safety Specialist

Location:
Hillsborough, North Carolina, 27278, United States
Posted:
October 05, 2016

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Resume:

Thelon N. Holman (Becky)

*** *** ****** ****

Chapel Hill, NC 27516

919-***-****

acwxen@r.postjobfree.com

PROFESSIONAL SUMMARY

Over ten (10) years combined experience in pharmacoviligance and as a safety specialist in the clinical research field. Therapeutic experience includes: Oncology, HIV, Multiple Myeloma, Renal, Breast, Prostate, Colon, Melanoma, Diabetes Mellitus, Coagulation Defects, Anxiety, Bipolar, Manic-Depression, ADHD (adult and children), Alzheimer’s, Multiple Sclerosis, Angina Pectoris, MI, COPD, Gastroenterology, Lupus Nephritis, ALS, Dermatitis, Osteoporosis, Bone Marrow, and Cardiology.

PROFESSIONAL EXPERIENCE:

JUN/16-AUG/16 – INC Research, US Regional – Sr. Safety Specialist (Contract). Responsible for case processing, narrative writing, SUSAR Submission, Internal Sponsor Meetings, SAE Queries submission, study specific start up forms, monthly line listings, WHO and MedDra coding, Perform monthly SAE reconciliation. SMP preparation for study start-up, SAE notifications to sponsors as well as INC team members. . Provides back-up support as safety specialist.

JUL/15-OCT/15: Precision for Medicine, Frederick, MD – Sr. Drug Safety Specialist (Contract). Responsible for writing PVG SOP’s. Processing all AE/SAE and SUSAR cases for Medical Device Phase IV Post Marketing surveillance study. Responsible for preparing study specific study start up forms, as well as participating in all study start up kick off meetings. Preform monthly reconciliation activities between clinical databases and safety databases. Identifies and prepares SAE case queries for assigned clinical trials in collaboration with Safety Physician. Participates in therapeutic area case management meetings for assigned clinical programs. Participate in monthly signal detection meetings with PVG and Regulatory departments. Assist in the preparing of DSUR’s, PADER, and PSUR reports.

JUN/14-Nov/14: Medimmune/AstraZeneca, Gaithersburg, MD (Aerotek) Pharmacovigilance Support Specialist (Contract) Responsible for preparing study specific reporting forms and completes other required study set-up forms. Participates in clinical trial team meetings assigned trials/programs. Reviews protocol to ensure standard safety language is included and to identify any study specific safety reporting requirements. Participates where appropriate in CRA and Investigator Training including creation of slides and training materials. Assists in creating Safety Data Management Plans. Preforms reconciliation activities between clinical databases and safety databases. Identifies and prepares SAE case queries for assigned clinical trials in collaboration with Safety Physician. Participates in therapeutic area case management meetings for assigned clinical programs. Provides back-up support to the case handling group undertaking safety report intake, processing and reporting activities when required on an ad hoc basis. May also provide additional support to Sr. PV Ops Support Specialist for other development programs. Preparing CAPA reports for PVG risk management.

DEC/13-Jan/14: Clinipace Worldwide, Morrisville, NC Sr. Pharmacovigilance & Safety Specialist (Contract) Responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

JUN/12 – Aug/13: PPD, Morrisville, NC Senior Safety Specialist Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports, and reporting activities. Code adverse event terms and write narratives according to client convention. Case Triage in STS as well as PRIMO. Peer QC non-serious and serious cases. Assist with preparation and review of regulatory reports. Review literature articles/abstracts and process adverse event reports from literature per program and regulatory requirements. Maintain knowledge and understanding of PPD and client-provided SOPs and current regulations. Coding of all AE and SAE using WHO and MedDRA version 15.1 according project specific coding guidelines. Effectively communicate with team members, client contacts and adverse event reporters. Submission of quarterly and annual PADER and PSUR reports. NDA and BLA filing. Medical Record review and processing for serious and non-serious cases. Processing of serious, non-serious, expected and unexpected cases. Generating queries, line listing reports, monthly AE reconciliation reports, In charge of disaster recovery logs and back up of flash drives on weekly basis. Processing of FU cases and making phone calls to appropriate HCP. Processing of monthly Literature Surveillance for specific clients. Submission of CIOMS (EU) and MedWatch (FDA) reports for specific clients. Rewriting OG’s, DEG’s and SOP as it pertains to the project. Create case folder in Live Link and make sure all source documents, PCR, AE Capture documentation, CIOMS and MedWatch reports are uploaded for each case. Write deviation/CAPA reports. FDA audits preparing required source documents as it pertains to PVG as well as any PVG documents that are requested during the audit,

NOV/10 – APR/12: Foushee Tax & Financial Management Company, Chapel Hill, NC Business Manager Maintain and update CEO’s calendar for daily meetings and travel. IT management. Maintain office supplies for office. Budget Management for travel expenses, AP, AR, reconciles monthly credit card receipts, reconcile bank statements. Arrange all travel and meetings as well as setting up and arrangement of all conference calls for CEO. Create Power Point presentations. Maintain Excel Spreadsheets and Outlook calendar. Contract negotiation for vendors and subcontractors. Assist CEO with major Project Management deliverables as well as research and assisting with all major projects for NC as well as DC offices. Payroll and HR Manager for NC and DC office. Tax preparer for Individual clients. Limited travel to DC office to assist with large scale project for DC and Federal Government projects. Database Management/Entering Data into Access.

JUL/07 – OCT/10: Quintiles CRO, Morrisville, NC Sr. CEVA Specialist/Drug Safety Associate (Contract)

Applied medical and clinical knowledge and judgment to analyze reported adverse events, assessing their completeness and accuracy. Interacted with investigational sites after the assessment to assist with the accurate reporting of adverse events. Participated in continuous improvement of all departmental processes and procedures. Performed triage, case evaluation, data entry, and narrative creation for initial and follow-up adverse event reports. Receive and facilitate the submission of expedited and non-expedited safety reports to regulatory authorities, and the sponsor within the allotted time frame of submission 7 days for expedited and 14 days for non-expedited cases. Performed as back-up Pharmacovigilance team lead on medium-large size projects. Performed as team lead on complex small/medium size projects. Maintained knowledge and understanding of client provided SOPs and current FDA regulations. Responding to queries. Participate in the triaging of safety reports for regulatory reporting purposes as well as QC cases to ensure the accuracy and completeness of information entered into the safety database.

FEB/07 – JUN/07: Coram Healthcare, Morrisville, NC Clinical Safety Specialist (Contract)

Case prioritization based on seriousness of adverse events in accordance with SOPs (Standard Operating Procedures) and regulatory guidelines. Reviews medical record follow up to cases in

Litigation in accordance with US FDA Regulations. Analyzes and extract pertinent information from medical records in accordance with legal and US FDA safety regulations. Creates comprehensive narrative procured from relevant legal case documents and medical records as determined by regulatory and SOP guidelines. Data enters relevant information from completed extraction form from MRT or CRO (Clinical Research Organizations) into Argus LAM. Identifies and follow department procedures for AEs associated with product complaints.

MAR/06 – FEB/07: Maureen Joy Charter School, Durham, NC Director of Operations/Office Manager (Contract) Maintained IT system: SIMS (Student Information Management System). Maintained IT system: NC Wise for State of NC Department of Public Instruction. Performed activities for payroll, accounts payable and accounts receivable. Contract negotiation for all vendors as well as creating budget not only for vendors but for the Board of Directors as it pertained to the business of the school. HR Manager performing all HR functions. Member of policy committee for functions of all school programs and afterschool program. Supervised office staff of four employees on a daily basis. Grant submission of after school program. Assisted with creating annual budget for school as well as after school programs. Benefits coordinator. Assisted with school audit by CPA firm as well as state audit by food and nutrition services. Maintained all student files. Database management.

JUN/04 – MAR/06: Struever Bros. Eccles & Rouse, Inc., Durham, NC Executive Assistant/Assistant Project Manager Responsible for day to day operations of development office. Managing a variety of projects as the general contractors/developers for the American Tobacco Project (200 million dollar project). Performed activities for payroll, accounts payable, and accounts receivable. Executive Assistant to CEO, CFO, Development Director and Project Attorney. Developing the coordination of the ATC Art Project, which consisted of putting together the RFP and RFI? Setting panel committee for RFP review and overseeing the project from start to completing. Community Development Coordinator. Submitting AIA Documents. Creating advanced power point presentations to be used in training by development, construction and legal departments. Data entry.

APR/00 – JUN/04: PPD Medical Communication, Durham, NC SAE Coordinator/Nurse Consultant (Contract) performed the execution of work for the Pharmacovigilance Department including the receipt, monitoring, processing and entry/reporting safety reports for Eli Lilly studies. Ensured the accuracy and completeness of safety information entered in the SAE safety database (Clintrace) for submission to regulatory authorities. Maintained effective relationships with clients and site personnel. Providing customers with complete and accurate information. Responsible for the execution of work strategy of the Pharmacovigilance. Department including the receipt, monitoring, processing, entry and reporting of safety reports. Perform other related duties as assigned or requested by the Manager, Pharmacovigilance. Entering data into Safety Database.

EDUCATION, LICENSURE & CERTIFICATION

Howard University BSN

Keller Graduate School of Management - present MBA

Keller Graduate School of Management – present MPM

TECHNICAL SKILLS

Microsoft Office, Excel, QuickBooks, One Note, WordPerfect, AS500, Timberline, Invoice Router, Lotus, Intranet, Access, SIMS, CECAS, NC Wise, MS Project 2002 & 2003, and Power Point, SAP, Clintrace, ARGUS, Infotrack, Catool, Inform, ARISg, ARES 4.6.1, Sapphire, RAVE, Angel MedDRA and WHO coding.



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