Profile: 10 + years of experience in the field of Pharmacovigilance which includes case processing, quality reviewer, operations manager, auditor, analyst and pharmacovigilance trainer and 8 months of experience as clinical research coordinator. Detailed knowledge of GVP, CIOMS, FDA and ICH guidelines including understanding of regulatory requirements. Successfully faced FDA inspection which was happened first time for KPO industry (was POC during inspection period). Have knowledge on Analytics and part of automation team as subject matter expert. Outstanding interpersonal skills; equally comfortable communicating one-on-one or addressing large audiences. Solid ability to translate technical information. Strong influence, negotiation, and diplomacy skills. Key Skills: Argus database • Narrative writing • Having experience in processing literature, spontaneous, solicited cases ICH GCP guidelines, Schedule Y, OCRDC data entry. Languages known • English, Hindi, Kannada and Telugu. Area of Interest • Pharmacovigilance, Medical writing, clinical research, team operation. Can conduct audits for any English-speaking countries. Based in Hyderabad.