Kiran Singh J
Global Safety Lead | Tech- Domain Infusion Lead | Associate General Manager - PV/MI at HCLTECH
- Role
- Associate General Manager at HCLTech
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Kiran Singh J
Pharmacovigilance & Gen AI Transformation Leader | Safety Systems SME | Regulatory Tech StrategistExperienced life sciences professional with over 15 years in global pharmacovigilance, medical writing, and regulatory domains. Proven track record in leading Gen AI–driven automation, safety systems strategy, and tech-domain infusion across the pharma value chain.Currently serving as Associate General Manager & Practice Lead – Pharmacovigilance & Medical Information at HCLTech, where I spearhead digital transformation initiatives, AI/ML projects, and client-centric PV solutions for global pharma and CRO clients.Core Specializations:Generative AI & Agentic AI across PV, Regulatory & Clinical• PV Systems Governance & Safety Compliance (GxP, 21 CFR Part 11, GDPR)• Content Automation & Reuse • Medical & Scientific Writing | NLP-Powered Content Modeling• Regulatory Submission Planning & Process Automation• Pre-sales Strategy | Business Analysis | PoC & MVP Development• Electronic Data Capture (EDC)| MedDRA | WHODD | RAVE• Cross-functional Team Management & Innovation DeliveryPassionate about driving AI adoption in life sciences, enabling scalable, compliant, and efficient pharmacovigilance ecosystems. I manage high-performing scientific writing and AI delivery teams, and collaborate with global stakeholders to build next-gen solutions aligned with health authority standards.
Experience
Associate General Manager
Jan 2024 — Present · IN
Education
K L E Society's College of Pharmacy
Bachelor of Pharmacy - BPharm
Vivekananda College of Pharmacy
Diploma in Pharmacy
PES College of Pharmacy
M Pharmacy, Pharmacology
2008 — 2010
Skills
- Pharmaceutics
- Pharmaceutical Industry
- Sop
- Drug Safety
- Life Sciences
- Standard Operating Procedure (Sop)
- Meddra
- Regulatory Affairs
- Regulatory Submissions
- Medicine
- Electronic Data Capture (Edc)
- Good Clinical Practice (Gcp)
- CRO
- Narrative
- Clinical Trials
- Clinical Development
- Clinical Data Management
- Clinical Research
- Gcp
- Ich-Gcp
- Medical Writing
- Oncology
- Clinical Monitoring
- Clinical Trial Management System (Ctms)
- Pharmacology
- Pharmacovigilance
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