Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Timeline
Generic
Ritama Bhar

Ritama Bhar

Mysore

Summary

Experienced Drug Safety Associate with a solid background in pharmacovigilance, focusing on ICSR processing and literature screening. Skilled in interpreting complex medical information and working closely with cross-functional teams to ensure accurate and timely safety reporting. Played an active role in coordinating team trainings, managing vendor communications, and maintaining clear documentation. Known for being reliable, detail-oriented, and someone who brings a positive, collaborative energy to the team.

Overview

1
1
year of professional experience

Work History

Drug Safety Associate

Sitero solutions Pvt. Ltd.
Mysore
04.2025 - Current
  • Performed processing of Individual Case Safety Reports (ICSRs) in compliance with global regulatory timelines.
  • Conduct triage of incoming safety data from clinical trials, ensuring accurate classification and prioritization of Individual Case Safety Reports (ICSRs).
  • Perform comprehensive case processing, including data entry, coding and narrative writing in compliance with regulatory and sponsor requirements.
  • Communicated effectively with clients and clinical trial sites to clarify safety data, resolve queries, and ensure timely and accurate case processing in compliance with regulatory standards.
  • Applied standardized medical coding using MedDRA, WHODD, and company-specific dictionaries for drugs, events, and lab tests.
  • Collaborate with cross-functional teams to resolve data discrepancies, and clarify missing or ambiguous information.
  • Contributed to internal pharmacovigilance training initiatives and knowledge sharing.

Drug Safety Associate - Trainee

Sitero solutions Pvt. Ltd.
Mysore
06.2024 - 04.2025
  • Performed a primary review and quality review of literature abstracts and full-text articles to identify safety-relevant information and potential ICSRs.
  • Screened literature to identify potential Individual Case Safety Reports (ICSRs), and other safety-relevant information.
  • Collaborated with cross-functional teams to ensure timely, accurate literature screening deliverables.
  • Tracked and maintained records of internal and client-specific training completion for all team members.
  • Communicated with external vendors to request and order full-text, and translated literature articles as needed for pharmacovigilance activities.
  • Maintained records of ordered articles, and tracked their status to support literature screening and regulatory compliance.

Education

Masters of Pharmacy - Industrial Pharmacy

JSS College Of Pharmacy
Mysore
05-2024

Bachelor of Pharmacy -

SRM College Of Pharmacy
Chennai
06-2021

Skills

  • LSMV and ArisG databases
  • MedDRA dictionary
  • Embase search
  • Literature screening
  • Communication
  • Time management
  • Multitasking capacity
  • Learning agility
  • Collaborative teamwork

Accomplishments

  • Best performer of the month_ Literature review

Languages

English
First Language
English
Intermediate (B1)
B1
Hindi
Intermediate (B1)
B1
Bengali
Intermediate (B1)
B1

Timeline

Drug Safety Associate

Sitero solutions Pvt. Ltd.
04.2025 - Current

Drug Safety Associate - Trainee

Sitero solutions Pvt. Ltd.
06.2024 - 04.2025

Masters of Pharmacy - Industrial Pharmacy

JSS College Of Pharmacy

Bachelor of Pharmacy -

SRM College Of Pharmacy

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Ritama Bhar