Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Generic
Sabera Jabin Pathan

Sabera Jabin Pathan

Edinburgh,Scotland

Summary

As an Operations Scientist holding Double Master’s Degrees in Pharmacology and Drug Design and Biomedical Sciences, I bring several years of experience in pharmacovigilance, adverse event reporting, and regulatory compliance. My expertise includes monitoring, reviewing, and analyzing safety data, preparing reports, and ensuring compliance with FDA and EMA guidelines. I have also developed strong skills in communication, problem-solving, and teamwork, and am well-versed in pharmacovigilance databases such as SCEPTRE and Aris G. With a keen eye for detail and a commitment to quality, I am confident in my ability to support drug safety efforts and contribute to the success of any organization.

Overview

7
7
years of professional experience
8
8
Certification

Work History

Operations Scientist

IQVIA Research India Pvt. Ltd
Bangalore, Karnataka, India
10.2014 - 07.2021
  • With 6.9 years of experience in Pharmacovigilance, I, ., where I handled the Johnson & Johnson project
  • My key responsibilities included case processing and quality review of ICSRs
  • I possess domain expertise in using safety databases such as SCEPTRE and Aris Global and have detailed knowledge of pharmacovigilance regulations and processes
  • I am trained in case processing, triage, and quality review, including coding and narrative writing, and am a subject matter expert in Quality Review and Medical Device Reports
  • Proficient in collecting, processing, and monitoring of serious adverse event (SAE) reports and non-serious adverse event (NSAE) reports according to applicable regulations, Guidelines (GDLs), Standard Operating Procedures (SOPs) and project requirements
  • Skilled in generating safety narratives and queries and follow-up requests to ensure accurate safety information is available
  • Experienced in conducting safety database data entry in SCEPTRE and Aris G and performing quality control of safety cases
  • Capable of producing investigator safety letters and reconciling SAE reports between safety and clinical databases; and can perform effectiveness checks
  • Proven track record of attending internal and external meetings, including audits/inspections
  • Demonstrated ability to lead clinical trial projects, ensuring timely delivery of client deliverables and providing oversight and compliance reports
  • Identify process deviations and prepare timely CAPA files to ensure process improvement and compliance
  • Provided training to the new hires when required.

Education

Master of Science - Drug Design and Biomedical Sciences

Edinburgh Napier University
02.2023

Master of Science - Pharmacology

Shri Vasavi Institute of Pharmaceutical Sciences
01.2013

Bachelor of Science - Pharmacy

Korangi College of Pharmacy
01.2011

Skills

  • Physical Skills
  • Proficient in conducting extensive telephone and face-to-face communication with high accuracy in speech perception
  • Skilled in using keyboard for prolonged periods with excellent proficiency in MS Office tools
  • Effective Multitasking
  • Problem-Solving
  • Team Collaboration
  • RCA CAPA
  • Audits
  • Pharmacovigilance
  • Effectiveness Checks

Certification

  • SAS Programming for R Users from LinkedIn.
  • Lean Six Sigma for a Sustainable Future from LinkedIn.
  • Root Cause Analysis: Getting to the Root of Business Problems from Project Management Institute (PMI).
  • Graduate Employability Masterclasses – Gold from SULSA - Scottish Universities Life Sciences Alliance.
  • Cybersecurity Outsourcing: Vendor Selection and Management from LinkedIn.
  • PG diploma in Clinical Data Management from Syncorp Clincare Technology Pvt Ltd.
  • PG diploma in Pharmacovigilance from Syncorp Clincare Technology Pvt Ltd.
  • PG Diploma and three months internship experience in SAS from Syncorp Clincare Technology Pvt Ltd

Accomplishments

  • Received promotions twice within 4 years in IQVIA RDS (India) Private Limited, Bangalore, India.
  • I have been awarded “Bravo” for the contribution towards “Teamwork”.
  • I have been awarded “Applause” for the contribution towards “Quality”.
  • I have been awarded “Bravo” twice for the contribution towards “Productivity”.
  • I received a “Star Performer” award during Sep-Dec 2017 for making difference in company, culture, and customers and for my dedication and service.
  • Received a medal twice for participating in ORDI – Racefor7 which was all about – raising awareness for rare diseases in 2020 and 2021.

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Sabera Jabin Pathan