Varun Subramanya Email and Phone Number

 Medicine graduate with 17 Years of working experience in Clinical Research, Health Care & Pharma Industries, CRO’s specifically in Pharmacovigilance including clinical trial phase I-IV.  Experience in Clinical Research & regulatory affairs. Familiar with ICH-GCP Guidelines and related health authority regulations from US FDA, Health Canada, EMEA, MHRA, SAHPRA (South Africa), Brazilian Health Regulatory Agency (Anvisa), TGA (Australia), DCGI/ CDSCO (India), MFDS (South Korea), PFDA (Philippines), National Pharmaceutical Regulatory Agency (NPRA) Malaysia, DOH (Hong Kong), HAS (Singapore), Thailand FDA, Taiwan FDA, Med safe New Zealand, CDE of NMPA (China) & PMDA (Japan). Involved in launching new Pharmacovigilance center in Dalian (CHINA) and providing training on Pharmacovigilance for new staff in Dalian, China. Safety database user acceptance testing (UAT) and data migration implementation, effort estimation & invoicing. Primary Skills in - clinical trials/ pharmacovigilance/ drug safety, ICSR report processing including clinical trial, literature report processing, vaccine safety monitoring and medical device regulatory reporting. SME within certain topics like product quality complaints, pregnancy report processing, SUSAR case processing, E2B submissions, expectedness / labelling/ causality assessment of an event, MedDRA coding, briefing on product safety information or RSI’s, Narrative writing, database functionality SME working in ARGUS, ARISG, SCEPTRE & Veeva vault safety database, involved in automation & implementation process, PSUR, DSUR, regulatory submission, SMP, RMP, clinical monitoring, aggregate reporting, Medical writing, and Project management.  Responsible to manage drug safety projects including participation in RFI, RFP, work order / purchase order management, MSA / charter management, contracts proposal, monthly monitoring of revenue recognition / invoicing using pricing tools, operations management, vendor management, handling escalations or issues, participating in audit/ inspections and driving CAPAs, resource calculation and assignment, support hiring by participating as panelist in conducting technical interviews. Bachelor degree in herbal medicine. Master’s degree in management and experienced in operations/ people management, business development/ strategic planning and LEAN SIGMA practitioner. Primary care physician. Responsible for Diagnosis, treatment, and referrals of the patients.