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Ishan Gupta
Drug Safety / Pharmacovigilance professional
Drug Safety / Pharmacovigilance professional
Ishan Gupta is a Drug Safety / Pharmacovigilance professional with 9 years of experience managing end-to-end ICSR case processing, regulatory compliance, and inspection readiness in global pharmaceutical environments. He has extensive expertise in Argus Safety, MedDRA/WHODrug coding, literature surveillance, and quality documentation. Known for leading teams, mentoring associates, handling escalations, and optimizing PV workflows, Ishan ensures timely and audit-ready safety deliverables aligned with EMA, FDA, MHRA, and GVP regulations. He consistently drives quality, collaboration, and operational efficiency across pharmacovigilance functions.
FORMERLY AT
Qinecsa Solutions
LOCATION
Karnataka
AVAILABILITY
Full-time
Skills
Argus Safety
Literature Surveillance Tools
LSMV
MedDRA
MS Office
PV documentation tools
WHODrug
Work Experience
Drug Safety / Pharmacovigilance professional
Qinecsa Solutions
November 2020 – Present
- Serves as primary point of contact (SPOC) for safety case escalations, delivery assurance, and client communication.
- Manages end-to-end ICSR processing with MedDRA and WHODrug coding, including triage, data entry, QC, and closure.
- Conducts literature monitoring via LSMV and ensures inspection readiness.
- Supports SOP updates, CAPA documentation, and PV workflow transitions.
- Mentors junior associates, conducts training, and drives performance improvement.
TECHNOLOGIES
Argus Safety, LSMV, MedDRA, WHODrug, PV documentation tools
Drug Safety Associate II
Novo Nordisk
March 2016 – March 2020
- Processed and submitted 1,500+ ICSRs via Argus Safety in alignment with global regulatory timelines.
- Performed narrative writing, causality assessment, and supported medical review.
- Conducted literature surveillance and handled MedDRA coding.
- Assisted in audit readiness activities and trained new associates on PV workflow and triage.
TECHNOLOGIES
Argus Safety, MedDRA, Literature Surveillance Tools, MS Office
