Shubham User
@shubhamuser29
I improve pharmacovigilance case quality, regulatory submissions, and team performance across global safety operations.
IndiaWhat I'm looking for
I'm currently improving quality review and team performance at IQVIA, reviewing clinical trial, PMS, PSP, literature, and spontaneous cases. I mentor more than 30 associates and helped new hires increase productivity by 80% in 1.5 months while maintaining quality.
At Cognizant Technology Solutions, I managed expedited ICSR distribution and submissions, including E2B, CIOMS, and MedWatch 3500A reports, within regulatory timelines. I also served as the primary POC for Distribution and Submission during internal and client audits and contributed to database migration through script analysis.
Across my pharmacovigilance work, I've handled ICSR intake, triage, data entry, quality review, submission, literature monitoring, reconciliation, query management, MedDRA coding, narrative writing, and case corrections. I consistently achieved 130% of quarterly targets in my Junior Data Analyst role.
I've built my career in drug safety operations at Wipro, Cognizant, and IQVIA, combining hands-on case processing with quality control, mentoring, audit support, and process improvement. I'm a Bachelor of Pharmaceutical Technology graduate from Jadavpur University.
Experience
Work history, roles, and key accomplishments
Performed quality review of clinical trial, PMS, PSP, literature, and spontaneous cases. Mentored over 30 associates, improving new hire productivity by 80% in 1.5 months.
SME for ICSR distribution and submission, expediting submissions to health authorities and partners. Key contributor in database migration and primary POC during audits.
Managed ICSR intake, triage, data entry, quality review, and submission within TAT. Consistently achieved 130% of targets each quarter.
Supported quality control activities and routed cases to medical review workflow. Provided quality audit scores and feedback to case processors.
Reviewed and assessed source documents, compiled data in client safety database, and raised follow-up queries. Performed MedDRA coding and narrative writing.
Education
Degrees, certifications, and relevant coursework
Jadavpur University
Bachelor of Technology, Pharmaceutical Technology
2015 - 2019
Grade: 7.1 CGPA
Bachelor of Pharmaceutical Technology from Jadavpur University, completed in 2019.
Vivekananda Siksha Niketan High School
Higher Secondary, General Studies
2012 - 2014
Grade: 71%
Higher Secondary education completed in 2014.
Vivekananda Siksha Niketan High School
Secondary, General Studies
2011 - 2012
Grade: 79%
Secondary education completed in 2012.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Salary expectations
Job categories
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