Summary
Overview
Work History
Education
Skills
Hobbies and Interests
Timeline
Generic
Dr. Pakki Kausik

Dr. Pakki Kausik

Bengaluru

Summary

Pharmacovigilance professional with more than 5 years of experience in end-to-end Individual case safety report (ICSR) processing.

Overview

6
6
years of professional experience

Work History

Pharmacovigilance Services Analyst

Accenture
Bengaluru
09.2024 - Current
  • Served as subject matter expert for clinical trial cases.
  • Conducted training and quality checks for new team members.
  • Tracked production metrics and priorities management in the absence of team lead to ensure workflow continuity.
  • Acted as the point of contact for compliance checks and client data protection activities.
  • Managed end-to-end processing of individual case safety reports (ICSR) to uphold regulatory compliance.

Drug Safety Associate

Accenture
Bengaluru
07.2021 - 08.2024
  • Reviewed and evaluated adverse event case information to determine necessary actions based on internal policies.
  • Conducted manual data migration to ensure accuracy of records.
  • Encoded verbatims using MedDRA dictionary, products with company product dictionary, and WHO drug dictionary.
  • Written comprehensive safety narratives.
  • Attached appropriate queries to resolve missing or discrepant information efficiently.
  • Executed additional drug safety-related tasks and ad hoc activities as assigned.

Junior Drug Safety Associate

Bioclinica (Clario)
Mysuru
11.2019 - 07.2021
  • Managed diverse case types, including serious and non-serious spontaneous, phase 4 and interventional clinical trial cases.
  • Codified all medical history, events, drugs, procedures, indications, and laboratory tests using MedDRA and WHO-DD dictionaries.
  • Assessed labeling information to ensure compliance with ICSR requirements.
  • Written comprehensive safety narratives for various cases.
  • Developed queries for missing or inconsistent information to enhance data integrity.

Education

Doctor of Pharmacy -

Avanthi Institute of Pharmaceutical Sciences
Visakhapatnam
06.2019

Skills

  • Safety database management (ArisG, LSMV, LSMV-NAVAX)
  • Attention to detail
  • Communication skills
  • Time management
  • Team collaboration
  • Team building
  • Adaptability

Hobbies and Interests

  • Reading novels
  • Writing lyrics (Telugu)
  • Writing short-stories

Timeline

Pharmacovigilance Services Analyst

Accenture
09.2024 - Current

Drug Safety Associate

Accenture
07.2021 - 08.2024

Junior Drug Safety Associate

Bioclinica (Clario)
11.2019 - 07.2021

Doctor of Pharmacy -

Avanthi Institute of Pharmaceutical Sciences

Similar Profiles

CREATE PROFILE
Dr. Pakki Kausik