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Shiv Kulkarni
Pharmacovigilance and Drug Safety professional
Pharmacovigilance and Drug Safety professional
Shiv Kulkarni is a Pharmacovigilance and Drug Safety professional with over 10 years of experience supporting global clinical trials and PV operations within a leading pharmaceutical client (Roche). He specializes in ICSR processing, regulatory narrative writing, MedDRA coding, eCRF safety review, and safety data reconciliation. Shiv is highly skilled in safety systems including ARISg, LifeSphere Multivigilance (LSMV), Clinical Veeva Vault, and Smart Query tools. Known for maintaining 100% regulatory compliance, leading UAT activities, and managing multiple high-priority projects independently. Recognized with multiple performance awards for quality, efficiency, and process innovation.
FORMERLY AT
Tata Consultancy Services
LOCATION
Mumbai
AVAILABILITY
Full-time
Skills
ARISg
LifeSphere Multivigilance (LSMV)
MedDRA
MS Office
Smart Query Tool
Veeva Vault Clinical
Work Experience
Pharmacovigilance and Drug Safety professional
Tata Consultancy Services
2014 – Present
- Conduct eCRF reviews across multiple study types (IVDR, ATMP, ophthalmology, legacy EP eCRFs).
- Manage eTMF uploads, AERO UAT reviews, and end-of-study blind break activities.
- Process ICSRs from IRT to ARISg, perform regulatory narrative writing, and assess seriousness, causality, and labeling.
- Collaborate with Roche stakeholders to address safety queries (SAE, SUSAR, SAR) and ensure regulatory timelines are met.
- Maintain inspection readiness, adhere to SOPs, and mentor team members on PV workflow and disease biology.
TECHNOLOGIES
ARISg, LifeSphere Multivigilance (LSMV), Smart Query Tool, Veeva Vault Clinical, MedDRA, MS Office
