Summary
Overview
Work History
Education
Skills
Timeline
Generic

Radhika Sankaranarayanan

Wangaratta,VIC

Summary

Provide expertise in pharmacovigilance services and be open to more learning opportunities in pharmacovigilance. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

8
8
years of professional experience

Work History

Assistant Manager

Wipro
04.2021 - 06.2023
  • Responsible for review of medical literature articles to identify drug safety related issues.
  • Identification of individual case safety reports (ICSR) from literature articles and write concise summary of these ICSRs.
  • Entry of safety data into database with appropriate use of MedDRA coding.

Drug Safety Executive

Lupin Limited (Fidelity)
06.2018 - 03.2021
  • Clinical Safety Submission
  • Preparation of safety management plan including SAE report form and pregnancy report form.
  • Prepare training material for serious adverse event (SAE) reporting requirements for investigators during Site Initiation Visit (SIV)
  • Responsible for co ordination between sponsor and site regarding adverse events notification.
  • Preparation of clinical safety file for submission to Trial master file.
  • Maintain updates in clinical study tracker at DSRM. Submission of ICSR to respective regulatory authority including USFDA, EMA.
  • Preparation of SAE docket for submission to DCGI.
  • SAE reconciliation between clinical and safety database. Review of patient narratives and safety data in clinical study report and safety section in draft protocol.
  • Data entry and Quality Review in Argus Database
  • Triage, book in and case processing of ICSR’s in ARGUS database which includes clinical trial cases, spontaneous reports, literature cases, MLM and L2A cases, courtesy reports and other reports from health authorities.
  • Proficient knowledge in using MedDRA, WHO-DD dictionary.
  • Reviewing and writing safety narrative for ICSR.
  • Prioritization of cases in accordance with expedited criteria and determining countries to which cases should be expedited.

Senior Drug Safety Associate

Bioclinica
07.2017 - 06.2018
  • Hands on experience of ARISg 6.1 database.
  • Review of source documents including physician’s medical records/pharmacy records/complaints received from marketing programs etc.
  • Data Entry of the adverse events report (AE) form from source docs including patients demographical data, suspect and concomitants, narrative, selection and detailing of adverse events, action taken, dechallenge and rechallenge, medical history and diagnostic details.
  • Causality assessment and quality review for non-serious cases.
  • Listedness assessment of adverse events (AE) using various labelling documents.
  • Delivering the ICSR on various case types including spontaneous, PMS study and PASS study.

Drug Safety Associate

Tata Consultancy Services
07.2015 - 07.2017
  • Fully Proficient in all responsibilities of IRT case entry. Accountable for confirming whether IRT data fields are entered against source document as per applicable guidelines and SOPs.
  • Responsible for evaluating cases assigned as invalid reports and assigning invalid reports to pre archive folder in IRT.
  • Subject matter expert in handling communication with health care professionals through IRT communication module.

Education

Bachelor of Pharmacy - Pharmacy

Savitribai Phule Pune University
Pune
04.2015

Skills

    Drug safety

    Literature monitoring

    MedDRA coding

    Medical writing

Timeline

Assistant Manager

Wipro
04.2021 - 06.2023

Drug Safety Executive

Lupin Limited (Fidelity)
06.2018 - 03.2021

Senior Drug Safety Associate

Bioclinica
07.2017 - 06.2018

Drug Safety Associate

Tata Consultancy Services
07.2015 - 07.2017

Bachelor of Pharmacy - Pharmacy

Savitribai Phule Pune University

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Radhika Sankaranarayanan