Summary
Overview
Work History
Education
Skills
Timeline
Generic
FLAVIA THOMAS

FLAVIA THOMAS

Coventry

Summary

Enthusiastic, dedicated Pharmacovigilance expert with One and half years of experience in Clinical and Pharmacovigilance, including Case processing, booking, data entry, MedDRA and Narrative Writing.

Medical Evaluation of ICSR, Aggregate Reports, Signal Detection, and Risk Management. Analysis, Risk Evaluation, Mitigation Strategies, and medical assessment/ evaluation as well.
Eager to contribute to team success through hard work, attention to detail, and excellent organizational skills. Trained & Certified with a Clear understanding of Pharmacovigilance and Clinical trials.
Motivated to learn, grow and excel in the field. Critical thinker with a background in developing and improving methodologies and procedures for superior data analysis and reporting.

Overview

5
5
years of professional experience

Work History

Drug Safety Associate

IQVIA
KOCHI
11.2021 - 04.2022
  • Mastered art of case intake, duplicate search, evaluation of adverse events, and case registration using Argus software.
  • Processes about 10 -15 cases per day by routing case to next workflow.
  • Progressed to achieving complete case processing using medical coding and narrative writing in compliance with SMP and ICH guidelines.
  • Achieved award for best quality team.
  • Promoted to Quality Control (QC) role where cases were checked and forwarded for Final Case Review (FCR) status which was then moved to Regulatory Authorities (RA).
  • Worked on action to prevent noncompliance and late reporting. Participated in investigations to develop plans for corrective and preventative action.
  • Delivered work by understanding significance of position and explaining how it fits into larger departmental structure while being mindful of upstream and downstream operations.
  • Showcased inspection readiness through personal efforts and knowledge of objectives of audits and inspections.
  • Mentored new associates, performed daily checks on team quality, and maintained timely reports about team’s compliance.
  • Documented non-compliance with CAPA form.
  • Familiar with WHO, CIOMS and EMA terms in signal detection.

Trainee Drug Safety Associate

IQVIA
KOCHI
10.2020 - 11.2021
  • Assisted with regular data entry and case processing of about 6- 10 cases per day, quality control, workflow management, data retrieval, and data entry of individual case safety reports (ICSRs), including narrative writing
  • Trained hands-on expedited safety reporting of Regulatory Authorities (EMA, MHRA, HPRA) and perform Country Affiliates' operational assistance.
  • Worked in collaborations with third parties (TPOs), such as Patient Support Programs (PSP), market research firms, medical information providers, and digital media companies for aggregation of adverse event data.
  • Performed regular triage of incoming cases for daily workflow management Perform quality control activities to ensure complete and accurate case information.
  • Performed regular case intake, duplicate search, evaluation of adverse events, and case registration using Argus software.
  • Progressed to achieving complete case processing using medical coding and narrative writing in compliance with SMP and ICH guidelines.
  • Data retrieval from safety database, as needed Perform database reconciliation of AE/SAE,
  • Well-trained in using Argus, Safety Easy databases, including MedDRA & WHODD
  • Worked flexible hours across night , weekend and holiday shifts

Pharmacist

GEO MEDICALS
KOCHI
10.2017 - 09.2020
  • Educated patients about possible drug interactions and gave special administration instructions.
  • Dispensed and verified patient prescription orders, conducting necessary utilization reviews.
  • Educated patients on proper medication use.
  • Provided advice on health issues, symptoms and medications.
  • Administered prescription medications to public.
  • Taught patients how to use medical devices such as glucose meters and oximeters.
  • Maintained effective levels of medicines and supplies to meet expected demand.
  • Counselled patients regarding proper intake of medications.
  • Assisted other pharmacy staff with drug inventory, purchasing and receiving.

Education

Master of Science - GLOBAL HEALTHCARE MANAGEMENT

COVENTRY UNIVERSITY
COVENTRY
04.2023

Master of Pharmacy - PHARMACEUTICS

ST. JOSEPH'S COLLEGE OF PHARMACY
KERALA , INDIA
09.2017

BACHELOR OF PHARMACY - PHARMACY

SRI RAMAKRISHNA INSTITUTE OF MEDICAL SCIENCES
COIMBATORE, INDIA
09.2014

High School Diploma -

KENDRIYA VIDYALAYA
KOCHI , INDIA
06.2010

Skills

  • Case processing on Argus & safety
  • Medical Assessment
  • Duplicate Search
  • Case Closure
  • Translation
  • Processing ICSR (Individual Case Safety Reports)
  • Case Triage, Processing information from EDC (Electronic Data Capture)
  • MedDRA Coding
  • Narrative writing
  • Excellent Medical assessment
  • Knowledge of safety databases (Argus & Safety Easy), FDA Industry Guidelines, ICH Guidelines
  • Capacity for taking feedback in constructive way
  • Adheres to confidentiality requirements and procedures and is aware of how to identify and safeguard company information
  • Effective and simple communicative skills
  • Capable of setting workload priorities and finishing all deliverables by deadlines
  • Effectively escalates challenges and makes potential remedies based on own experiences
  • Knowledge of pre-and post-marketing Pharmacovigilance
  • Excellent knowledge of Microsoft Office: PowerPoint, Word, Excel Good written and oral communication skills
  • Excellent Working knowledge and familiarity with medical terminology
  • Ability to learn quickly and flexible , adaptable to quick changing environment
  • Ability to work collaboratively as part of team Self-motivation and ability to drive results independently
  • Excellent time management and organizational skills
  • Detail-oriented

Timeline

Drug Safety Associate

IQVIA
11.2021 - 04.2022

Trainee Drug Safety Associate

IQVIA
10.2020 - 11.2021

Pharmacist

GEO MEDICALS
10.2017 - 09.2020

Master of Science - GLOBAL HEALTHCARE MANAGEMENT

COVENTRY UNIVERSITY

Master of Pharmacy - PHARMACEUTICS

ST. JOSEPH'S COLLEGE OF PHARMACY

BACHELOR OF PHARMACY - PHARMACY

SRI RAMAKRISHNA INSTITUTE OF MEDICAL SCIENCES

High School Diploma -

KENDRIYA VIDYALAYA

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