Data Entry Certified Phlebotomist

Tabassum Hayat *****.********@*****.***

M.D. MSHI 650-***-****

Orlando, Fl

Summary

•5 years of pharmaceutical industry experience in both post marketing and clinical trials.

•Drafted individual casesummaryreportsandwroteconcisecasespecificnarrativesaspercompany/product conventions.

•Prepared clinical narrative summaries independently for AE reports from clinical studies and spontaneous post- marketing reports and formulated follow-up information as per requests.

•Analytical and results-oriented Drug Safety Associate and validation specialist with 4years experience collaborating as a strong team player in Pharmaceutical and medical industry.

•Proficient in consistent coding of diseases, adverse events, and medication according to the Project specific coding conventions Excellent knowledge of US FDA, EMA and ICH-GCP guidelines, reporting requirements for EU region and all other regulations applicable to drug safety.

•Expertise in writing the case narratives for ICSRs for both clinical and post-marketing cases, as per company’s/client’s narrative template.

•Generated queries to obtain missing case information and clarifications in Electronic Data Capture and analyze, and present scientific and medical data in verbal and written format.

•Experience working on life cycle of drugs and excellent knowledge in drug development, medical literature search and PV regulation, Knowledge, and experience with GCP, ICH, SOP and FDA guidelines in both clinical research and drug safety related field.

•Experience with and trained in drug safety specialty area with case intake, ICSR – Validate cases criteria, Triage, book-in, assessment, duplicate-check, Data entry in Argus, seriousness, expectedness, case processing, Narratives, follow up’s, Quality check and help with timely Submissions, MedDRA coding, knowledge and assist with processing electronic reporting (E2B) and expedited safety reports, help to ensuring successful timely submission.

•Hands on experience with ICSR, IRB review, regulatory authorities, Ethics Committees, Protocol submission, Liaise with Investigators, and sponsors on timely basis to assure the workflow stay compliant.

Work Experiences:

PV Safety Reviewer December 2019- Present

PPD, Morrisville, NC

•Responsible for Medical Review of ICSR/SAES Safety profile/ the post marketing/clinical study

reports of undesirable effects involving products collected in US/Canada/ROW and countries without

medical expertise.

•Lead signal detection/aggregate reports as safety expert a, Identify, monitor and analyze potential

safety signals analyze safety data, writing of periodic cumulative analysis and assessment of the post

marketing /clinical study safety data analysis for product class for internal and external purposes

working closely with product safety, data management Toxicology team.

•Regular Interaction with CRO/Vendors responsible for NDA submissions of products

•Evaluate prepared Med Watch for serious reactions and response letters interaction with FDA on

received CAERS reports assessing the Expectedness of the reactions.

•Contributes to the quality compliance with the international standard operating procedures for post

marketing safety surveillance activities, in countries without local medical skill (standard

questionnaires, support for inquiries - compulsory medical expertise)

•Regular interactions with the other departments involved in the safety evaluation, regulatory in

particular pre-marketing safety and development laboratories.

•Partnered with Team Lead in acting as an active participant in new implementations and client

meetings.

•Ensured that all internal and -specific activities are performed in compliance with appropriate

Regulatory requirements.

•Assisted in Working Practice development and updates to ensure accurate reflection of processes

Maintained awareness of essential trends related to business operations by monitoring publicly

available information.

•Input to Aggregate reports/ DSUR/risk management plans, changes to SmPC, Benefit Risk

•Evaluation, NDA Submission, labeling, investigator brochures, CSR’s protocol writing, amendments,

inclusion/exclusion criteria

•Review safety narratives/SAE reconciliations and submit for follow up/corrections if needed.

Reviewed and assess causality of all serious adverse experiences.

•Responsible for follow up events and providing medical and scientific information to health care.

Pharmacovigilance Associate, Jan 2017 - Nov 2019

IQVIA, Raleigh, NC.

•Perform quality review for adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs).

•Data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database and performing quality check of ICSRs.

•Analyzed cumulative investigational and marketed product adverse event reports for inclusion in Periodic Safety Update Reports.

•Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.

•Basic working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports.

•Understanding of medical terminology and the ability to summarize medical information.

•Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.

•Processed serious adverse event information per sponsor’s standard operating procedures.

•Submitted ICSR’s to the regulatory authorities within timelines for compliance.

•Performed medical coding using MedDRA and WHO DD.

•Monitor electronic mailboxes to ensure timely acceptance of Adverse Event (AE) Reports and perform data entry into databases, as needed.

•Reviewed spontaneous reports as well as cases from clinical trials for marketed and investigational compounds to determine regulatory reporting responsibilities.

•Perform SAE reconciliation on a periodic basis and at DLP.

•Raised SAE queries to Investigative sites and CRAs as needed.

Epic physician Trainer May 2015 - Dec 2016

Multiple Hospitals, USA

•Provided Epic EMR training to physicians and clinical providers on multiple settings.

•Work with Content Team Analysts to help design and manage a variety of internal and external terminology related projects. Select and collect medical data from patient records.

•Providing hands-on knowledge of operating systems as well as strategic services related to value-based care. Provide expanded strategic research, consulting capabilities, technology, and analytic solutions to help, manage and retort to client conditions and disentangle healthcare challenges.

Occupational Health & Safety Specialist Oct 2014- March 2015 Boeing Company, WA

•Perform risk assessments, and incident investigations to identify & reduce workplace risk factors in Airplane assembly areas by recommending cost-effective solutions.

•Perform cost of injury avoidance analysis to justify the business case for engineering solutions

•Provide recommendations for short term and long-term solutions including behavioral and engineering controls.

Medical Record Release Specialist June 2011-Nov 2011

Stanford Hospital, CA

•Retrieve health information for HIM correspondence from hospital-designated sources.

•Prepare, scan, and upload medical requests, authorizations & medical records in accordance with HIPAA.

Medical Officer, Sep 2005- Dec 2010

Defence Medical Center Karachi, Pak

•Prevent, diagnose and treat various diseases and physical in

•juries in children and adult

•Diagnosing diseases based on test results and interpreting possible complications.

•Formulate treatment plans, prescribing medications, and dress wounded areas.

Resident House Officer Surgery and Medical Dept: Sep 2004-Aug 2005

LUMHS, Pakistan

•Clinical rotations in medicine, surgery, pediatrics, obstetrics and gynecology

•Shadowed expert Physicians in the management of patients with a variety of health conditions requiring medical intervention.

•Helped Physicians examine and treat patients by assisting them with instruments, injections and medications.

Skills:

•Expertise in using MedDRA for medical coding of all events, CDD (company drug dictionary) and WHO drug dictionary for coding products and good knowledge in scientific terms and medical terminology

•Experienced in processing and medical review of Individual case safety reports (ICSR)

•AEs/SAEs reports, spontaneous, regulatory authority, literature, and clinical trial case reports.

•FDA (21CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc.

•Oracle Argus

•EPIC Provider Customization Expert

Education:

•Advance Drug Safety and Pharmacovigilance Jan 2023

•Master’s in health information management University of south Florida, Tampa (Jan 2022)

•Doctor of Medicine, MD LUMHS (2003)

•OSHA Labor & Industry Certification Compliance Training (2016)

•CPR & First Aid Certified American Academy of CPR & First Aid (2010)

•Certified Phlebotomist West Broward School for Nursing (2006)

Languages:

•English – Fluent

•Urdu – Native

•Hindi – Advance

•Punjabi, Sindhi- Communicable

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