Prashanth Dixit

About Prashanth Dixit

Experienced Life Sciences professional with 14 years across Consulting, CRO, and Sponsor organizations. Proven expertise in regulatory document automation using GenAI, cognitive safety case processing applications, E2B implementations with health authorities and license partners, and production support. Successfully led the setup of a Pharmacovigilance (PV) department for an Indian CRO and spearheaded the creation of in-house signal detection tools.Key AccomplishmentsManaged a 250+ Project Team as STE for PI Planning Activities. Handled Cross ART Dependencies, Risks, Issues. Jira Align Setup & Review.Directed E2B Profile Development and Lead Production Support for Elevate Safety Database, ensuring seamless data exchange and regulatory compliance.Designed and Launched a Cost-Effective Signal Detection Tool for a mid-size Korean PharmaEstablished PV Department in a leading Indian CRO; defined business requirements for proprietary signal detection systems, resulting in streamlined processes and enhanced regulatory readiness.Core Competencies-Business Analysis in Life Sciences-Automation of Regulatory Document Drafting (GenAI)-Agile Project Delivery-Project and Production Support Management-ICSR Processing (Drugs & Devices)-Periodic Safety Reports (DSUR)-Literature Surveillance & Signal Detection-Developing Safety Management Plans, SOPs, and Work Instructions

Experience

1. Manager

   Deloitte

   Jun 2023 — Present · Bengaluru, IN

   Solution Train Engineer for Regulatory Content Automation Project-Business Analysis for GenAI authoring of Safety documents in Regulatory Submission-E2B Pilot with HA & LP for a Japanese Pharma-Lead for E2B & Gateway Implementation-Support for Configuration & Data Migration-Providing key SME inputs for Safety System Functionalities

Education

• K.V.G Dental College & Hospital, Sullia, under Rajeev Gandhi University Of Health Sciences

  B.D.S, 69

  2004 — 2009

• CLINIMINDS, Bangalore

  Post Graduate Diploma, Clinical Trial Management

  2010 — 2010

Skills

• Adverse Event Reporting
• Clinical Research
• Medical Writing
• Argus Safety
• Clinical Data Management
• Oracle Clinical
• Good Clinical Practice (Gcp)
• Ich-Gcp
• Standard Operating Procedure (Sop)
• Meddra
• Drug Cases
• Regulatory Submissions
• Gcp
• Narrative
• Pharmacovigilance
• Pharmaceutical Industry
• Sop
• Fda
• Drug Safety
• Edc
• Pharmacology
• Triage
• Who Drl
• CRO
• Sceptre
• Literature
• Clinical Development
• Irt
• Clinical Trials
• Life Sciences
• Regulatory Affairs