Summary
Overview
Work History
Education
Skills
Conferences And Presentations
Clinical Research Project - Academic Project
Accomplishments
Timeline
Generic

Blessy Lavanya Kaki

Colfax,NC

Summary

Pharm.D. graduate with 1 year of clinical internship and 6 months of contract experience in pharmacovigilance operations. Worked as a Drug Safety Associate at Tech Mahindra, supporting global clients including Pfizer and GSK, where responsibilities included processing over 1,100 Individual Case Safety Reports (ICSRs), MedDRA coding, and ensuring regulatory compliance with ICH-GCP, FDA, and EMA standards. Clinical internship involved hands-on exposure in hospital departments such as Internal Medicine and Pediatrics, with a focus on therapeutic evaluation, medication safety, and adverse event documentation. Proficient in Argus Safety, Excel, and trained in SAS and SQL, with a strong commitment to data accuracy, regulatory compliance, and patient safety.

Overview

1
1
years of professional experience
1
1

Intern Experience

Work History

Drug Safety Associate

Tech Mahindra
Hyderabad, India
10.2015 - 04.2016
  • Supported global pharmacovigilance operations for clients including Pfizer and GlaxoSmithKline (GSK).
  • Independently processed and submitted over 1,100 Individual Case Safety Reports (ICSRs) in Argus Safety, ensuring full compliance with FDA, EMA, and ICH-GCP standards.
  • Conducted triage, seriousness, and causality assessments using WHO-UMC criteria; consistently coded adverse events using MedDRA
  • Monitored and evaluated adverse events and potential medication-related risks to support signal detection and safety surveillance initiatives.
  • Maintained over 99% accuracy in safety case submissions and documentation.
  • Collaborated with global regulatory teams to improve safety data integrity and streamline follow-up processes.

Intern Doctor

Government Hospital
Chidambaram, Tamil Nadu
08.2013 - 08.2014
  • Completed internship rotation in internal medicine, general surgery, obstetrics and gynecology, and pediatrics.
  • Conducted therapeutic evaluations ensuring optimal medication effectiveness.
  • Updated patient records pertaining to treatment and care.
  • Evaluated nursing notes to confirm accuracy of care provided and patient responses.
  • Maintained strict patient data procedures to comply with HIPAA laws and prevent information breaches.
  • Explained potential prognoses of diseases or traumatic conditions.
  • Met with patients to discuss needs, conduct tests and evaluate clinical presentations.

Education

Doctor of Pharmacy -

Annamalai University
Tamil Nadu, India

Skills

  • ICH-GCP
  • Clinical documentation
  • Regulatory compliance
  • Microsoft Excel
  • Clinical SAS
  • Effective communication
  • MedDRA
  • Adverse event reporting
  • Risk assessment
  • Signal detection
  • Microsoft Word
  • PowerPoint
  • Argus Safety
  • WHO-ART
  • Drug safety regulations
  • Pharmacovigilance expertise

Conferences And Presentations

  • Poster Presenter – Pediatric Gastroenteritis Study, ICPG, Confidential - Oracle Restricted, Chennai, Tamil Nadu, 600001
  • Delegate – Indian Society of Hypertension, BPCON 2011
  • Participant – DST Entrepreneurship Awareness Camp, Annamalai University
  • Delegate – 64th Indian Pharmaceutical Congress, SRM University

Clinical Research Project - Academic Project

Effect of Nebulization Combinations in Pediatric WALRI Patients, Conducted a 6-month prospective observational study on over 65 pediatric patients to evaluate the effectiveness of bronchodilator combinations. Collected and analyzed symptom progression and treatment outcomes using Microsoft Excel, contributing to optimized therapeutic decision-making. Authored and presented findings as part of final Pharm.D thesis, receiving positive faculty feedback for clinical relevance and analytical rigor.

Accomplishments

  • Certificate of AppreciationRTNDDS Seminar, Puducherry
    For active participation and academic engagement in novel drug delivery systems workshop (RTNDDS 2013).
  • SAS Project Completion ExcellenceOrien IT, Hyderabad
    Completed hands-on clinical SAS training with distinction, demonstrating exceptional grasp of base SAS for healthcare datasets.

Timeline

Drug Safety Associate

Tech Mahindra
10.2015 - 04.2016

Intern Doctor

Government Hospital
08.2013 - 08.2014

Doctor of Pharmacy -

Annamalai University
Blessy Lavanya Kaki