Summary
Overview
Work History
Education
Skills
Languages
Projects
Timeline
Generic

CHERUKUTHOTA SAI LAHARI

Bangalore,KA

Summary

Graduate with Pharm.D degree and proven 4+ years of experience in Pharmacovigilance, looking for challenging roles in Pharma IT sector. Strong attention in detail, time management, Experience in working with cross functional teams and ability to work independently in a team. Aiming to use my proven skills to effectively fill the Associate consultant role in your organization.

Overview

4
4
years of professional experience

Work History

Quality check Reviewer

IQVIA India Pvt. Ltd
  • As a Quality check reviewer, create and maintain a robust system for reporting and monitoring cases to regulators
  • Lead projects with vendors or internal teams for safety improvement
  • Evaluate cases in the workflow for reporting needs and report as required by SOP
  • Provide the feedback to the mentees for the errors noted to improve of the case
  • Standard operating procedures writing and maintaining the impact of change and how to measure the effectiveness while creating and maintaining documentation to support the PV department
  • Responsible for late case analysis and CAPA management
  • Responsible for identifying root cause for failed cases.

Literature Review specialist

  • Ensure effective and accurate collection, recording, review and reporting of literature searches conducted
  • Ensure quality of literature searches and reporting
  • Review of local/global literature reports to determine regional report ability
  • Create/maintain study summary documents.

Senior Drug safety associate

IQVIA India Pvt. Ltd
09.2021 - 06.2023
  • Completion of case processing (case data entry, labeling, approval numbers, manual coding, narrative writing) and quality review Handling of non-serious and serious adverse events of oncology drugs, biologics and other clinical drugs related to project based
  • Performing FAER, SUSAR, Spontaneous cases, Clinical trial cases and legal cases and verification of reported non-serious and serious adverse events; entered the reported information in the database – Argus, AgXchange, ArisG on the basis of individual case history
  • Ensure accurate and consistent coding of all events for serious and non serious cases entered with the use of MedDRA (Medical Dictionary for Regulatory Activities), WHODD
  • Possessed Knowledge of Common Toxicity Criteria (CTC), Drug development and clinical trial experience
  • Evaluate causality, seriousness and listedness for all cases
  • Perform various tasks in support of our clients’ clinical research including: adverse event analysis and processing
  • Ensure that case narrative comprises correct and appropriate safety information
  • Assess the need for follow up information and issue follow up requests for all cases and post queries in EDC and/or to affiliate
  • Scheduling regulatory reports with the regulatory timelines
  • Request deletions/Admin edit requests
  • Preparation of safety reports for submission to various health authorities
  • Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards
  • Safety document or data analysis
  • Adherence to project timelines, with proactive communication to project managers and clients, as needed
  • Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and Standard Operating Procedures (SOPs)
  • Leverage internal data systems and tools to efficiently maintain data and reporting processes to reduce manual data retrieval
  • Recommend operational process improvements, both within the department and division-wide
  • Continually remain apprised of the constantly changing landscape of the healthcare industry and any potential impacts it may have to our business and our clients
  • Analyze stakeholder complaints related to safety reporting, address in real time, and discuss with project managers and/or clients to mitigate risk and implement/drive realistic solutions
  • Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor.

Safety associate trainee and safety associate

03.2019 - 08.2021
  • As a case intake member (Intake, triage, Duplicate check, Data entry)
  • Managing a team of safety, starting from case distribution, doubt clarifications and attending client calls and updating the team with the new information received from clients
  • Daily administrative work for the team members which includes one to one meeting to find out disconnects in knowledge as well as team behaviors and to improve the pulse of the team
  • Conducts team discussion for both processing and product knowledge
  • Raising PQC and translation requests prior to timelines.

Education

DOCTOR OF PHARMACY -

Sree Vidyanikethan College of Pharmacy, Sri Venkateshwara Institute of Medical Sciences (SVIMS) University
01.2019

Skills

  • Medical terminology
  • Knowledge of Good Clinical Practice (GCP), GDP, and International Conference on Harmonization (ICH) guidelines
  • Clinical data management, clinical research and Pharmacovigilance
  • SQL, Power BI, Tableau, Basics of SAS
  • MS word, Advanced Excel, MS Outlook, MS PowerPoint

Languages

English
Telugu

Projects

A CROSS SECTIONAL STUDY ON EFFECT OF DISTRESS DUE TO DISEASE, ON MEDICATION ADHERENCE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS IN A TERTIARY CARE, four months, Tirupati, The study was carried out in a tertiary care teaching hospital at Tirupati with duration of four months at the department of Endocrinology outpatient.

Timeline

Senior Drug safety associate

IQVIA India Pvt. Ltd
09.2021 - 06.2023

Safety associate trainee and safety associate

03.2019 - 08.2021

Quality check Reviewer

IQVIA India Pvt. Ltd

Literature Review specialist

DOCTOR OF PHARMACY -

Sree Vidyanikethan College of Pharmacy, Sri Venkateshwara Institute of Medical Sciences (SVIMS) University

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