Summary
Overview
Work History
Education
Skills
Timeline
Generic

Gurpreet Kour Randhawa

Caledon,ON

Summary

Dynamic Healthcare professional with 5+year of experience in Pharmacovigilance domain. Skilled in handling client queries, Pharmacovigliance, and data validation, Responsible for all safety-related aspects of a product- single case assessment and Quality Review of ICSRs (Individual Case Safety Reports). Applicable knowledge of labeling and labeling documents i.e, IB, SPC, USPI, CCDS. Strong leadership skills with an ability to build develop and lead result-oriented teams. Willing to learn latest technologies and implement them. Strong communication and interpersonal skill.

Overview

5
5
years of professional experience

Work History

Sr. Drug Safety Associate- Pfizer, USA

Bioclinica (Clario)
04.2021 - 05.2022
  • Expertise in management of Individual Case Safety Report (ICSR) that includes triage, initiation, data entry and narrative writing (ADRs/ ADEs), and Quality Reviews of ICSRs.
  • Review adverse event (AE) report data for completeness and verify certain fields to determine critical as well as conformity to E2B standards.
  • Worked on COVID-19 vaccine manufactured by one of the world's leading Pharma companies (Pfizer).
  • Skilled in Follow-up process, case report submission, adverse event (AE) reporting, quality assurance and regulatory compliance for ICSRs (SUSAR, Clinical trials, Literature, Spontaneous and Solicited) in ARGUS, ARISG and Ag tracker database.
  • Responsible for coding all medical history, events, drugs/procedures/indications, and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).
  • Thorough understanding of ICH, GVP, GDP, GCP, GMP, Health Canada GVP and familiarity with US FDA, MHRA-EMEA regulatory requirements.
  • Update error tracker for QC & assessment of cases.
  • Data entry, labeling, medical coding & narrative writing of Non- interventional PMS (post marketing surveillance) cases received from Japan, China, and Canada with fatal, serious & non-serious complexity.
  • Assessing valid & non-valid single ICSRs in the literature & sending them either for data basing in Argus database or rejecting with appropriate comment strictly adhering to the literature SOP
  • Outstanding prioritization skills and multitasking ability to meet tight deadlines.

Drug Safety Associate- Daiichi Sankyo, Japan

Cognizant
11.2019 - 03.2021
  • Performed Quality review, case processing, submission and timely reporting of Over 5000 Individual Case Safety Reports (ICSRs) from over 90 countries in accordance with company Standard Operating Procedures (SOP) for reporting to Regulatory Authorities (including FDA, MHRA and Health Canada).
  • Proficient in coding of adverse events, medical history, concomitant disease using MedDRA dictionary, fluent in medical terminology with practical knowledge of ICH-GMP guidelines and FDA, EMEA, TGA regulations.
  • Initial follow-up activities to obtain additional information and clarification, as appropriate.
  • Forward cases for case review or invalid workflow safety database.
  • Peer Review the cases and evaluate for accuracy, consistency and completeness in the safety database against the source document. This include, but not limited to checking the consistency of narrative and other data fields, ensuring main reasons for any delay is entered in the routing comment as appropriate.
  • Other activities relating to case processing as appropriate per case, including but not limited to Single case unbinding, SAE/AE reconciliation, deviation memo preparation, deletion/ administrative edit requests as needed.
  • Prepared and sent weekly and monthly reconciliation reports (including adverse event labeling, targeted Follow-up Questionnaire, Late case, Product Quality Complaint reports).

Process Associate-Roche, US

Tata Consultancy Services
08.2016 - 05.2019
  • Coded reported adverse events in the safety database (ARISG) including determining the report type, seriousness and expectedness/ labeling documents, writing case summaries/ narratives and assessing causalities to ensure complete, correct and timely reporting
  • Maintained knowledge of the adverse event safety profile of assigned drugs, reference safety information documents, data entry conventions and guidelines on safety, efficacy and FDA/ Health Canada guidelines
  • Maintained an awareness of the global regulatory obligations and organized workload to ensure compliance with the internal, external (clients) and regulatory timelines for adverse event reporting
  • Accountable for review of follow up cases for new medically significant information
  • Following up with sites regarding outstanding queries and reconciliation of discrepancies
  • Accountable for labeling (listedness) assessment and Causality Tagging from registered Reference Safety Information (RSI) for products like latest approved Investigator's Brochure (IB) or product/ Package Insert (PI)
  • Closures and deletion of cases requests
  • Generate action items and Create HCP Letter, CT query letter and GQ Questions if required for additional information
  • Prepare & update various documents like Training tracker, Update tracker, Error tracker, Client Tracker
  • Taking trainings for new associate & mentoring them.

Education

Bachelor's Degree - Pharmacy

Rungta College of Pharmaceutical Sciences&Research
Bhilai, Chhattisgarh
05.2016

Skills

  • Software/Applications: Microsoft Tools, Adobe
  • Database: ARISG, ARGUS, ag-exchange, MedDRA
  • Time management
  • Adaptability
  • Work ethic
  • Teamwork
  • Attention to detail
  • Communication skills
  • Interpersonal

Timeline

Sr. Drug Safety Associate- Pfizer, USA

Bioclinica (Clario)
04.2021 - 05.2022

Drug Safety Associate- Daiichi Sankyo, Japan

Cognizant
11.2019 - 03.2021

Process Associate-Roche, US

Tata Consultancy Services
08.2016 - 05.2019

Bachelor's Degree - Pharmacy

Rungta College of Pharmaceutical Sciences&Research

Similar Profiles

CREATE PROFILE
Gurpreet Kour Randhawa