Subuddha Yadav
Global patient safety
- Role
- Navi Mumbai at Cognizant
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Subuddha Yadav
Dynamic pharmacovigilance professional with 14+ years of progressive experience across case processing, quality review, training, process automation, and team leadership. Proven expertise in managing end‑to‑end drug safety operations, streamlining workflows, and driving process improvements with a strong focus on compliance and efficiency.Skilled in leading cross‑functional teams, capacity planning, resource management, and delivering high‑impact training programs. Hands‑on experience with industry‑leading safety databases including ArisG, AgXchange, LSMV, LitPro/LSLI, and ARGUS. Certified Lean Six Sigma (Bronze) with a track record of implementing automation solutions and process enhancements that optimize pharmacovigilance operations.Specialized in literature screening for ICSR & PSUR/Signal assessment, project transitions, and LSLI testing/documentation. Certified trainer for LSLI with expertise in SOP development and training material preparation. Recognized for strong people management, stakeholder collaboration, and the ability to deliver results in fast‑paced, regulated environments.
Experience
Navi Mumbai
Present
Structured entry of serious-non serious adverse events on to safety database ARIS G. Extraction of relevant information from routine source documents/ information coming from affiliate reports. Preliminary evaluation and assessment of case reports for seriousness, global listedness and causality of all serious-non serious adverse events. Accurate and timely entry of adverse events/serious adverse events taking in to account the automated case prioritization. Timely completion of action items assigned to the case. Creation of comprehensive case description (Narrative) in English language. Extracting relevant pharmacovigilance information from routine source documents. Requisition of clarification and additional pharmacovigilance information from affiliates. Verification of Meddra coding and WHODD coding. Accurately identify and capture any Adverse Event related to the drugs. Upgrade or downgrade of case, where applicable, following the medical assessment.
Education
B.R.Nahata college of pharmacy
M.pharm, All
2008 — 2010
Skills
- Quality Assurance
- Management
- Quality Reviews
- Regulatory Affairs
- Pharmaceutical Industry
- Sop
- Fda
- Quality Analysis
- Formulation
- Clinical Trials
- Gcp
- Workflow Management
- Team Management
- Pharmaceutics
- Regulatory Submissions
- Case Processing
- Ich-Gcp
- Validation
- Pharmacovigilance
- Gmp
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