Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Hana Waheed

Plano,TX

Summary

Skilled Pharmacovigilance Specialist focused on maximizing successful client outcomes through effective use of adverse event reporting, training compliance management, and quality assurance measures. Top-notch communicator with excellent time management, administrative and customer service skills.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Pharmacovigilance/eQMS Specialist

ProPharma
03.2021 - Current

· Followed all company policies and procedures to deliver quality work.

· Developed strong client relationships through consistent communication and attentive service.

· Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.

· Interpreted clients' needs and introduced services to fit specific requirements.

· Creation of cases in Argus Safety for adverse events relating to the COVID-19 vaccine manufactured by Novavax.

· Monitor inbox for incoming adverse event reports, and process reports in a timely manner.
Upholding quality standards for case reporting timelines.

· Performing data migration using MS Excel and Argus safety for Novavax.

· Assist in the implementation and maintenance of programs and processes in relation to document control.

· Ensuring that document control requirements are met throughout the duration of a document‘s Lifecyle.

· Perform QC of client cases to ensure accuracy and compliance

· 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.

Medical Receptionist

Lone Star Neurology
02.2018 - 01.2021
  • Checked patient insurance, demographic, and health history to keep information current.
  • Helped patients complete necessary medical forms and documentation.
  • Maintained strict confidentiality of patient information, adhering to HIPAA regulations and medical office policies.
  • Coordinated patient scheduling, check-in, check-out and payments for billing.
  • Provided patient education on procedures they would 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.
  • 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
  • Assisted in training new stockroom employees, contributing to a knowledgeable and efficient team.
  • Collaborated with faculty members to ensure appropriate quantities of chemicals were available for course experiments.
  • Assisted researchers with troubleshooting equipment issues or answering questions related to proper handling procedures.
  • 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 and graduate teaching assistants.
  • 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 - Biological Sciences

Texas A&M University - Commerce
Commerce, TX
12.2023

Bachelor of Arts - Biology

The University of Texas At Arlington
Arlington, TX
12.2018

Skills

  • Customer Relations
  • Expert Problem Solving
  • Documentation Management
  • Quality Assurance
  • Pivot Tables
  • Regulatory Compliance
  • Document Management
  • Training Compliance
  • Electronic Data Capture (EDC)
  • Electronic Quality Management System (eQMS)
  • Citrix
  • Jira

Certification

  • Advanced MedDRA Coding - 11th November, 2021
  • MedDRA Coding Basics - 4th November, 2021

Languages

English
Native or Bilingual
Urdu
Professional Working

Timeline

Pharmacovigilance/eQMS Specialist

ProPharma
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 - Biological Sciences

Texas A&M University - Commerce

Bachelor of Arts - Biology

The University of Texas At Arlington
Hana Waheed