Salesforce
Hana Waheed
eQMS Pharmacovigilance Specialist
Plano,TX
Summary
With a proven track record of success in previous roles, I consistently optimize task efficiency by modifying working instructions. I also play a vital role in ensuring departmental compliance with industry regulations. My meticulous attention to detail enables accurate data entry for adverse event cases. Leveraging these achievements, I am well-equipped to contribute to a dynamic and results-driven team.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Specialist
ProPharma Group
03.2021 - Current
- Creation of cases in Argus Safety for adverse events relating to pharmaceuticals manufactured by Novavax
- Proficiency with PV agreements, namely SMPs, client contact summaries, SOPs, etc
- Setting up new client agreements in eQMS (training compliance software) and revising/obsoleting the agreements as necessary
- Created SOP and Working Instruction templates for products related to Novavax
- Perform quality control in creation of SOP content
- Manipulation and exporting of client audit reports
- Maintained training compliance in preparation for client audits
- Communicated with vendors such as DOT Compliance in relation to updating and assessing PV agreements
- Assist in the implementation and maintenance of programs and processes in relation to document management
- Ensuring that document control requirements are met throughout the duration of a document's Lifecyle
- Ensuring appropriate filing, archival and obsoletion of controlled documents
- Supporting the delivery of training on Document Management and Control processes and the use of the Document Management System
- Following EU regulatory reporting guidelines and completion of cases within the specified time frame
- Use of ATC coding to appropriately code concomitant and suspect medications
- Follow regulatory Standard Operating Procedure guidelines
- Advanced knowledge of regulatory affairs and regulatory compliance requirements
- Perform ICSR check before submitting case to quality control
- Capturing Adverse events through the electronic data capturing system
- Writing ICSR narratives in accordance with the client's data entry manual
- Metrics reporting to maintain 100% compliance in Quality Management System
- Proficient use of Citrix Workspace
- Creating Excel spreadsheets to document cases in various workflow stages
- Accurate MedDRA coding of adverse events
- Accurate coding of pharmaceutical drugs using WHODrug global and NIH daily med
- Prepare written communications to obtain follow-up information
- MedWatch/CIOMS/E2B Preparation: Write case narratives and review MedWatch/CIOMS/E2B reports
- Receipt, processing, reporting, follow-up and reconciliation of adverse event reports from any source like clinical trials, literature, and post-marketing materials
- Obtain literature that provides evidence for adverse events
- Exporting overdue manager training reports and late department training reports, insertion of pivot tables to organize compliance reports.
Medical Receptionist
Lone Star Neurology
02.2018 - 01.2021
- Scheduling new and existing patient appointments and verifying insurance benefits in eClinicalWorks
- Providing patient education on procedures they will be having such as EEG, EMG, MRI, cerebral angiography, dementia testing, Alzheimer's testing, and stroke testing
- Served as a translator for urdu speaking patients
- Maintained and upheld strict HIPAA privacy policies at all times
- Performed other various tasks such as cash counting, administrative work, and faxing e-prescriptions.
Chemistry Stockroom Assistant
The University of Texas at Arlington
12.2017 - 12.2018
- Checked out laboratory equipment to students and professors, such as erlenmeyer flasks, test tubes, thermometers, leur lock syringes, etc
- Filled liquid nitrogen canisters for professors
- Stocked laboratories once weekly with sufficient materials for students
- Processed inbound and outbound packages, letters, and forms
- Arranged chemicals in stockroom according to safety guidelines in the MSDS sheet.
Education
Master of Science - MS in Biological Sciences - undefined
Texas A & M University-Commerce
Commerce, TX12.2023
Bachelor's degree in Biology - undefined
The University of Texas
Arlington, TX08.2018
Skills
- Events Management
- Citrix
- Regulatory Reporting
- Document Management Systems
- Document Management
- Quality Assurance
Certification
Advanced MedDRA Coding
Software
EQMS
JIRA
Timeline
Pharmacovigilance Specialist
ProPharma Group
03.2021 - Current
Medical Receptionist
Lone Star Neurology
02.2018 - 01.2021
Chemistry Stockroom Assistant
The University of Texas at Arlington
12.2017 - 12.2018
Master of Science - MS in Biological Sciences - undefined
Texas A & M University-Commerce
Bachelor's degree in Biology - undefined
The University of Texas
Advanced MedDRA Coding
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