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
Generative Ai
MS Office
Power BI
Data analysis
Data visualization and presentations
Excel
Quality Reviews
Pharmacovigilance Quality Reviewer
Case Processing
Drug Safety
Data Analytics Business Analyst
Workflow Management
Team Management
Data Analytics
Argus Safety
Arisg
MedDRA
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