Summary
Overview
Work History
Education
Skills
Personal information
Database skills
Languages
Projects
Linkedin
Timeline
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Suvam Sekhar Sahoo

Suvam Sekhar Sahoo

Mahanadivihar, Cuttack, Odisha

Summary

Pharmacovigilance professional with 6.5 years of experience in PV case processing with post-marketing cases. Accomplished professional with extensive expertise in drug safety and pharmacovigilance, specializing in case processing and clinical trials. Proficient in ICH-GCP guidelines, Quality review, Narrative writing, and regulatory submission with a strong command of MedDRA and adverse event reporting. Demonstrated success in regulatory submissions and post-market surveillance, utilizing databases such as ArisG, ARGUS, and Veeva. Committed to advancing public health through meticulous causality assessment and comprehensive literature review.

Overview

6
6
years of professional experience

Work History

Drug Safety Associate II

Qinecsa Solutions
12.2021 - 07.2025
  • Joined as Drug safety associate II in Qinecsa solution on (16 Dec 2021).
  • Working as PV case processing specialist with managing MLM submissions Tracker. I have experienced in tasks related to submissions, cases allocation, EMA feedback, maintaining EMA tracker, Duplicate management.
  • Processed literature cases in EV Web
    Mentoring newly joined associates and provide trainings for the individuals movement in workflow.
  • Performing the role of process trainer to improve the quality
  • Performs safety and pharmacovigilance program delivery activities including (but not limited to) all aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which includes cleaning and validation of data (xEVMPD product dictionary) manual recoding of substance/product terms arising from ICSR reports, management of duplicate ICSR cases, Quality review of ICSRs.
  • Ensures that the project/program activities are completed in accordance with agreed timelines, allocated budgets and required quality standards. Responsible for providing delivery and expertise with minimal oversight. Coordinates workflow to ensure delivery of project/program. Accountable to the Project Lead or Safety Program Delivery Manager at the project/program level and line manager for deliverables. May act as a mentor for less experienced associates. At a project level, may act as Safety Program Delivery Lead for local or regional studies.
  • I am currently involved in the activity of different type of Case processing with good knowledge on Post marketing Case processing (PMS), spontaneous, literature, solicited, and clinical trials cases and also involved in safety submission.
  • I have also processed literature cases daily basis and have a very good knowledge and hands-on experience in Literature case processing.
  • Performed ICSR End to end Case processing in ARISG and ARGUS safety database which includes serious and non-serious spontaneous and solicited cases.
  • Performed Prioritization and process cases received as per seriousness in order to meet timelines including medical coding (MedDra) and safety narrative.
  • Performed Listedness assessment of ICSR and ICSR reportability according to all applicable SOPs ad convention.
  • Performed ICSR processing including follow up, narrative completion, Meddra coding assessment and Causality assessment.

Junior Data Analyst

Cognizant Technology Solutions
01.2019 - 12.2021
  • Performed ICSR case processing in Arisg and Argus databases, which include serious, non-serious, spontaneous, and solicited cases.
  • Obtain and process Serious and non-serious adverse event (AE) data documented from clinical trials and/or postmarketing projects according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements.
  • Establish and maintain a thorough understanding of project protocol and scope of work (SOW) for assigned projects, set up and maintain project materials such as project files, forms, templates, databases and workflow.
  • Performed ICSR processing including follow up, narrative completion, Meddra coding assessment and Causality assessment.
  • Performed case initiation activity Handled all Product quality complaint, medical information, Co-markerter reconciliation activities.
  • I attended an audit and provided the client with information regarding the reconciliation process and ICSR case processing.
  • At Cognizant, Kolkata I became a Process trainer (SME) working from Oct-2020.

Education

Bachelor's in - Pharmacy

HI-TECH COLLEGE OF PHARMACY

Skills

  • PV Case processing
  • Drug Safety & Pharmacovigilance
  • ICSR End to end Case Processing
  • Safety submission reporting
  • Adverse event reporting
  • Clinical Trials
  • ICH-GCP Guidelines
  • Narrative writing
  • MedDRA
  • Literature Review
  • Risk assessment
  • Regulatory Submissions
  • Post-Market Surveillance
  • Causality assessment
  • PBRERs (Periodic Benefit-Risk Evaluation Reports)
  • PSUR (Periodic Safety Update Report)
  • DSUR (Development Safety Update Report)
  • Literature review
  • Project management
  • MS Excel
  • MS Word

Personal information

Database skills

  • ArisG
  • ARGUS
  • Veeva
  • ADEVER
  • Trackwise database

Languages

English
Proficient
C2
Hindi
Proficient
C2

Projects

Gastrointestinal Drug Therapies: A Comprehensive Review of Clinical Trial Evidence.

Linkedin

www.linkedin.com/in/suvam-sekhar-sahoo-b2431916b

Timeline

Drug Safety Associate II

Qinecsa Solutions
12.2021 - 07.2025

Junior Data Analyst

Cognizant Technology Solutions
01.2019 - 12.2021

Bachelor's in - Pharmacy

HI-TECH COLLEGE OF PHARMACY

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Suvam Sekhar Sahoo