Utpal Khambholja

About Utpal Khambholja

Medical Safety/PV Professional: Precision-centered and well-qualified Medical Safety, Pharmacovigilance, Signal Management and Surveillance Professional with more than 16 years of diverse experience in medical device, pharmaceutical, and clinical practice environments. Leverages skills in medical review, clinical research and PV assessments with strong knowledge of federal/international regulations to effectively monitor safety profiles of medical devices/drugs. Works effectively in collaborative settings; recognized for demonstrated excellence in leading all facets of clinical trials, blending follow-through with meticulous detail to ensure timely completion within established parameters. Adapts quickly to changing scientific environments and priorities, as well as new technologies, concepts, and information; academic qualifications include MD, MBA (Healthcare executive), CCRP designation, and current Six Sigma certification Blends a proactive management style with business-savvy insight and the technical acumen that streamlines operations, and improves processes, productivity, and profitabilityAREAS OF STRENGTH Clinical Research, PharmacovigilanceMedical SafetyRisk ManagementPost-market SurveillanceProject ManagementQuality and ComplianceClinical DevelopmentPhysician educationStaff Training/DevelopmentMDR/Vigilance/Post Market SurveillanceAudit support

Experience

1. Vice President Drug Safety and Pharmacovigilance

   Torl Biotherapeutics Llc

   May 2025 — Present · Los Angeles County, CA, US

   Develop and implement a global drug safety and PV strategy aligned with business objectives and regulatory standards • Represent safety perspectives in leadership meetings, risk committees, and external forums • Chair Safety & Risk Management Committees and maintain governance processes • Lead signal detection, benefit risk assessments, and evaluation of emerging safety data • Oversee medical review of adverse events from trials, post marketing, and real world sources • Design and manage Risk Management Plans, REMS, and post marketing surveillance systems • Ensure timely submission of expedited reports (ICSR, DSUR, PBRER) to global authorities • Prepare and lead responses to audits, inspections, and health authority queries • Maintain a compliant PV system (SOPs, PSMF, QMS) aligned with FDA, EMA, ICH, and global regulations • Manage global PV teams, internal staff, and external vendors/CROs • Oversee case management systems (e.g, Oracle Argus), database strategy, and technology tools • Lead PV budget planning, resource allocation, and vendor performance via KPIs and SLAs • Act as drug safety expert in clinical development, regulatory filings, medical affairs, and commercial planning • Provide safety input for Investigator Brochures, study protocols, labeling, and submission documents • Recruit, mentor, and develop high-performing PV professionals globally• Foster a safety-first culture, drive continuous improvement, and prepare teams for inspections

Education

• Vinnic'kij Deržavnij Medicnij Universitet im M.I.Pirogova

  Doctor of Medicine - MD, Internal Medicine Residency Program

• Vinnic'kij Deržavnij Medicnij Universitet im M.I.Pirogova

  Doctor of Medicine - MD, Internal Medicine

• Kriger Research Institute

  Certificate, CCRA program (Certification for Clinical Research Associate)

  2006 — 2007

• Vinnitsa State Pirogov Memorial University, Vinnitsa, Ukraine

  Doctorate, M.D, Major course of study and concentration in medicine

  1992 — 1999

• University of California, Berkeley

  Executive leadership program

• University of California, Irvine - The Paul Merage School of Business

  MBA (Healthcare Executive), Health/Health Care Administration/Management

  2014 — 2016

Skills

• Medical Devices
• Clinical Research
• Clinical Pharmacology
• Regulatory Affairs
• Post Market Surveillance
• Neurology
• Cardiology
• Medical Safety and Pharmacovigilance
• Biotechnology
• Nursing
• Oncology
• 21 Cfr Part 11
• Immunology
• CRO Management
• Safety Data Analysis
• Risk Management
• Ctms
• U.s. Title 21 Cfr Part 11 Regulation
• Diabetes
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Clinical Data Management
• Regulatory Submissions
• Good Clinical Practice (Gcp)
• CRO
• Ich-Gcp
• Clinical Development
• Clinical Trials
• Clinical Research Pharmacovigilance Medical Safety Risk Management Post-Market Surveillance Project Management Quality and Compliance Clinical Development Physician Education Staff Training/Development Mdr/Vigilance/Compliance Audit Support
• Sop
• Fda
• Clinical Research Experience
• Mdr
• U.s. Food and Drug Administration (Fda)
• Medicine