Thelon N. Holman (Becky)

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

Chapel Hill, NC 27516

ad2r2w@r.postjobfree.com

984-***-****

PROFESSIONAL SUMMARY:

Over fourteen (14) years combined experience in pharmacovigilance 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/22-Present: Travel Clinical Research Coordinator, Care Access, Remote & Travel –

Serving as the primary contact to ensure appropriate communications, trial management, and meeting of timelines

Coordinating the operational aspects of a new and ongoing clinical trial at the site

Working under the supervision of the Principal Investigator(s), while exercising excellent clinical judgment in patient monitoring and care

Maintaining daily contact with the Principal Investigator(s) for recruitment activities, study start-up, and general daily communication

Responsibility for the execution of the protocol and ensuring that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained on the protocol

Patient recruitment and pre-screening

Maintaining and submitting IRB communications and regulatory documents

Timely communications with internal teams, investigators, review boards, and study subjects

Preparing other study materials as requested by the Principal Investigator, such as informed consent documents, case report forms, enrollment logs, and drug/device accountability logs

DEC/20 – NOV/21: Drug Safety Manager, Clinical Trial Data Services, (PRN/Part time) – Remote

Responsible for evaluation, processing and reporting of serious adverse events in clinical trials in accordance with DSN Standard Operating Procedures (SOPs) and under the direction of the Director of Pharmacovigilance.

Tracking cases from receipt to closure, perform verification and evaluation of safety data, perform coding as outlined in the Safety Management Plan (SMP) and synthesize complex clinical information into accurate and complete narratives.

MEDDRA Coding, WHO Coding, as well at ATC Coding as it pertained to case processing.

Perform quality review of expedited and periodic ICSR and aggregate reports in order to ensure adherence to global case processing standards and regulatory requirements.

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.

MAY/20-AUG/20: Adverse Experience Reporting Coordinator; Merck- Remote

Provide expert guidance on the PV activities outlined by procedures (SOPs, User Manual, etc.).

Perform quality review of expedited and periodic ICSR and aggregate reports in order to ensure adherence to global case processing standards and regulatory requirements.

Identify, prioritize, and monitor quality issues to be resolved to maintain compliance.

Monitor group mailboxes utilized for the centralization of process/subject specific inquiries.

Support any other project or perform any other task deemed appropriate by management.

JUL/17 – APR/19: Safety Manager; Drug Safety Navigator (Contract) – Durham, NC

Responsible for evaluation, processing and reporting of serious adverse events in clinical trials in accordance with DSN Standard Operating Procedures (SOPs) and under the direction of the Director of Pharmacovigilance.

Tracking cases from receipt to closure, perform verification and evaluation of safety data, perform coding as outlined in the Safety Management Plan (SMP) and synthesize complex clinical information into accurate and complete narratives.

Utilizing good clinical and pharmacovigilance judgment that is compliant with all Good Clinical Practice (GCP) and regulatory requirements.

Working on clinical trial phases II - IV

MEDDRA Coding, WHO Coding, as well at ATC Coding as it pertained to case processing.

Maintained accurate audit-ready files and interacted daily with Sponsors, site personnel, and third-party vendors in the processing of serious adverse event information.

Served as the Safety lead on assigned projects Draft project specific study narratives per SOPs and Sponsor specific requirements utilizing medical records, SAE Report forms, data listings and other relevant documentation. Report all expedited safety reports to the appropriate regulatory authority(s).

Correspond with site personnel and CRA staff to gain full documentation for safety events and reconcile any inconsistencies.

Medical review medica/narrative writing.

Data Review as well as SAE/SUSAR review

Assist with safety reporting activities to outsourced partners to ensure that safety and pharmacovigilance needs are met and in compliance with all global regulations and applicable ICH/GCP guidelines.

Ensure safety issues are promptly communicated to the appropriate team members and/or Sponsors.

Perform quality check of SAE narratives and case entry as necessary.

Provide 24/7 coverage for the receipt and processing of SAEs, when necessary.

Interact with Data Management to ensure coding and events reported and recorded are consistent between departments.

Assist with the conduct of periodic internal reviews of safety systems, files and study-related documentation including the organization and oversight of the QC and QA review of all safety related projects in preparation for Agency submission and inclusion of narratives into a clinical study report.

Develop appropriate reports and safety communications as required by various Sponsors.

Assist with safety data collection and report training for staff. Perform ongoing safety database and systems validation.

Review product labeling for inclusion of applicable data in MedWatch reports for Medical device studies.

Identify errors in MedWatch reports submitted for approval and submission for Medical device studies.

Respond to inquiries and answer questions regarding MedWatch reports for Medical device studies.

JAN/17-MAR/17: Sr. Safety Specialist (Short term Contract)

Karyopharm Therapeutics- Newton, MA

Responsible for assisting with project migration of PVG cases into new document management system. 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.

Working on clinical trial phases II - IV

Medical review medica/narrative writing.

Data Review as well as SAE/SUSAR review

Perform monthly SAE reconciliation.

SMP preparation for study start-up, SAE notifications to sponsors as well as team members.

Provided back-up support as safety specialist.

JUN/16-OCT/16: Sr. Safety Specialist (Short term Contract); INC Research, US Regional

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-MAY/16: Sr. Drug Safety Specialist (Contract); Precision for Medicine, Frederick, MD

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.

Working on clinical trial phases II - IV

Medical review medica/narrative writing.

Data Review as well as SAE/SUSAR review

MEDDRA Coding, WHO Coding, as well at ATC Coding as it pertained to case processing.

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.

Review product labeling for inclusion of applicable data in MedWatch reports for Medical device studies.

Identify errors in MedWatch reports submitted for approval and submission for Medical device studies.

Respond to inquiries and answer questions regarding MedWatch reports for Medical device studies.

JUN/14-JUN/15: Sr. Pharmacovigilance Support Specialist (Contract); Medimmune/AstraZeneca, Gaithersburg, MD (Aerotek)

Responsible for preparing study specific reporting forms and completes other required study set-up forms. Participated 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.

Participated 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. Participated in therapeutic area case management meetings for assigned clinical programs.

Provided back-up support to the case handling group undertaking safety report intake, processing and reporting activities when required on an ad hoc basis.

Responsible for providing additional support to Sr. PV Ops Support Specialist for other development programs. Preparing CAPA reports for PVG risk management.

DEC/13-APR/14: Sr. Pharmacovigilance & Safety Specialist (Short term Contract): Clinipace Worldwide, Morrisville, NC

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. MeDra Coding, WHO Coding, as well at ATC Coding as it pertained to case processing.

JUN/12 – Aug/13: Safety Specialist;PPD, Morrisville, NC

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.

Working on clinical trial phases II - IV

Medical review medica/narrative writing.

Data Review as well as SAE/SUSAR review

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.

MEDDRA Coding, WHO Coding, as well at ATC Coding as it pertained to case processing.

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 to 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.

Review product labeling for inclusion of applicable data in MedWatch reports for Medical device studies.

Identify errors in MedWatch reports submitted for approval and submission for Medical device studies.

Respond to inquiries and answer questions regarding MedWatch reports for Medical device studies.

NOV/10 – APR/12: Business Manager; Foushee Tax & Financial Management Company, Chapel Hill, NC

Maintain and update CEO’s calendar for daily meetings and travel.

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.

Database Management/Entering Data into Access.

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

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 to appropriate regulatory agencies.

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.

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.

Review product labeling for inclusion of applicable data in MedWatch reports for Medical device studies.

Identify errors in MedWatch reports submitted for approval and submission for Medical device studies.

Respond to inquiries and answer questions regarding MedWatch reports for Medical device studies.

FEB/07 – JUN/07: Clinical Safety Specialist ; Coram Healthcare, Morrisville, NC

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.

MEDDRA Coding, WHO Coding, as well at ATC Coding as it pertained to case processing.

Creates comprehensive narrative procured from relevant legal case documents and medical records as determined by regulatory and SOP guidelines.

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.’

Populate, review, quality check and submit eMDR decisions via MedWatch to the FDA within specified deadlines.

Review product labeling for inclusion of applicable data in MedWatch reports for Medical device studies.

Identify errors in MedWatch reports submitted for approval and submission for Medical device studies.

Respond to inquiries and answer questions regarding MedWatch reports for Medical device studies.

MAR/06 – FEB/07: Director of Operations/Office Manager; Maureen Joy Charter School, Durham, NC

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.

Assisted with school audit by CPA firm as well as state audit by food and nutrition services.

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 completion.

Community Development Coordinator. Submitting AIA Documents. Creating advanced power point presentations to be used in training by development, construction and legal departments.

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.

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, Trackwise, RAVE, Angel MedDRA and WHO coding.

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