Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Hima Bindu Indireddy

Oakleigh South,Australia

Summary

Motivated and detail-oriented life sciences professional with over 4 years of experience in pharmacovigilance, regulatory compliance, and drug safety operations. Seeking to transition into a Clinical Research Associate (CRA) role, leveraging expertise in case processing, adverse event reporting, and stakeholder communication. Strong knowledge of ICH-GCP, clinical trial processes, and regulatory frameworks (including TGA requirements), with a commitment to ensuring patient safety, data integrity, and compliance in clinical research.

Overview

4
4
years of professional experience

Work History

MEDICAL SERVICE ANALYST

ACCENTURE
Bangalore, India
08.2021 - 03.2023
  • Responsible for end-to-end case reviewed in safety database starting from data entry, determining the adverse events, establishing the suspect drug, evaluating for expectedness (labelling) by using reference safety information (RSI), gauging the challenge and re-challenge and writing explanatory narratives.
  • Involved in clarification of unclear or illegible information from the Local Safety Officer or Call Centre and customer communication in accordance with the project requirement.
  • Interfaced with Medical Assessment Physician on source documents, coding conventions and adhoc queries.
  • Responsible for reviewed the coding of adverse events and drugs for consistencies as per regulators by using dictionaries like MedDRA for coding medical terminologies and WHODD for coding drugs.
  • Perform data entry for tracking, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality review, assisting with review and reconciliation of applicable reports, driving case closure, requesting translations and ensuring ICSR are processed within assigned timelines.
  • Address emails from different business stakeholders and customers supporting ICSR activities within timelines and seek clarifications where appropriate (Local Safety Officer (LSO), Pharmacovigilance Physicians (PVP), Customer POCs, safety operational mailbox, etc.)

DRUG SAFETY ASSOCIATE

IQVIA
Bangalore, India
01.2019 - 07.2021
  • Processed Individual Case Safety Reports (ICSRs) in line with global regulations, SOPs, and project requirements.
  • Identified workflow improvement opportunities, supporting process optimization and efficiency in safety operations.
  • Acted as Subject Matter Expert (SME) in safety reporting, providing mentoring to junior colleagues.
  • Developed expertise in clinical trial data management, narrative writing, and regulatory submissions.
  • Ensured compliance with GxP, MedDRA, WHO-DD, and CPD standards in daily operations.

Education

Bachelor of Pharmacy -

Raghavendra institute of pharmaceutical educational and research
Anantapur, AP, India
06.2017

Skills

  • Clinical Trials & GCP Compliance
  • Adverse Event & Case Processing
  • Regulatory Submissions (TGA, FDA, EMA)
  • Source Documentation & Data Verification
  • Narrative & Medical Writing
  • Stakeholder & Site Communication
  • Quality Assurance & Risk Management
  • MedDRA / WHO-DD Coding

References

Available on request

Timeline

MEDICAL SERVICE ANALYST

ACCENTURE
08.2021 - 03.2023

DRUG SAFETY ASSOCIATE

IQVIA
01.2019 - 07.2021

Bachelor of Pharmacy -

Raghavendra institute of pharmaceutical educational and research

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Hima Bindu Indireddy