Summary
Overview
Work History
Education
Skills
Certification
Social Links
Hobbies
Accomplishments
Timeline
Generic

Somnath Shinde

DATA ANALYST - PHARMACOVIGILANCE
Pune

Summary

Experienced Data Analyst specializing in pharmacovigilance. Demonstrated ability to effectively manage, analyze, and interpret pharmaceutical data to ensure patient safety and regulatory compliance. Proficient in data-driven tools and methodologies such as MS Excel, Power BI, with expertise in case processing and quality reviewing. Seeking opportunities to leverage skills and drive success in pharmacovigilance and data analytics.

Overview

12
12
years of professional experience
2028
2028
years of post-secondary education
3
3
Certifications
3
3
Languages

Work History

Data Analyst - Pharmacovigilance

Cognizant Technology solutions
02.2017 - Current
  • Proficiently handle the collection, processing, and evaluation of individual case safety reports in compliance with regulatory requirements
  • Ensure timely and accurate documentation of adverse events
  • Workflow management to ensure effective prioritization of work
  • Proper tracking of cases including inflow, prioritization and Productivity output on daily basis
  • Conduct daily huddle for the team and deliver updates to the team
  • Biweekly communication directly with the client and oversight teams regarding status of review
  • Prepared minutes of meetings (MOM)
  • Identify training needs based on quality review findings, prepare training calendars, and conduct training sessions for the team
  • Conduct daily huddles to deliver updates and improve team quality, mentor less experienced staff, and prepare training material for mentees
  • Performed processing of source data verification (SDV) received from vendors and internal affiliates, utilizing Power BI to visualize and create dashboards of the whole data
  • Manage client mailbox and served as the point of contact (POC) for the team

Drug Safety Associate

Tata Consultancy Services
08.2014 - 01.2017
  • Pharmacovigilance, case processing, Quality check

Research Associate

synapse labs pvt ltd
06.2013 - 08.2014
  • Designing and development of Informed Consent Form and Case Report Form
  • Obtaining of Informed Consent Form
  • Record past study adverse events and SAE in 'central medical record'
  • Ensures that all the activities performed are in accordance with the SOPs, Protocol and ICH-GCP or required regulatory guidelines
  • Reporting of adverse event and SAE's in Clinical database
  • Verifying that data entered on to the CRFs is consistent with source data
  • Compilation of essential document in Trial Master File
  • Archiving study documentation and correspondence

Education

MBA/PGDM - Operations

IBSAMS

B.Pharma - Pharmacy

Pune University
04.2001 - 01.2012

Skills

Train The Trainer

Certification

Project Genius - Generative AI

Social Links

LinkedIn, https://www.linkedin.com/in/somnath-shinde-a2224465/

Hobbies

Playing Cricket, Trekking, Swimming

Accomplishments

  • Developed an Excel-based follow-up query system that reduced processing time by 5 minutes and improved accuracy, leading to fewer compliance (CSL) issues.

Timeline

Data Analyst - Pharmacovigilance

Cognizant Technology solutions
02.2017 - Current

Drug Safety Associate

Tata Consultancy Services
08.2014 - 01.2017

Research Associate

synapse labs pvt ltd
06.2013 - 08.2014

B.Pharma - Pharmacy

Pune University
04.2001 - 01.2012

MBA/PGDM - Operations

IBSAMS

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Somnath ShindeDATA ANALYST - PHARMACOVIGILANCE