Ripal Gharia

Background

About Ripal Gharia

A highly organised medical professional with extensive experience in clinical development, and pharmacovigilance expert for various regulatory submissions such as FDA, EMA, and DCGI in all therapeutic areas predominantly oncology and biosimilars. Proven expertise in all therapeutic areas including, oncology, ophthalmology, cardiology, biosimilars, vaccines, and medical devices. Stellar record of leading and motivating colleagues and coworkers to achieve compliance in clinical trials and pharmacovigilance processes. Close rapport with KOLs and subject experts in various therapeutic areas and contributed to more than 70+ studies in different phases of drug development. Expert in handling client expectations and percolate the same to the team to make the project successful. Proliferated ability in consultancy for medical writing, medical monitoring, pharmacovigilance, regulatory affairs, and software development. Insightful business acumen to understand client requirements and convert it in operational deliverable and providing financial implications to costing and proposal team. Collaborating communicator focused on building the relationship and sound knowledge of clinical research & global regulatory requirements. Career Highlights • More than 25 Successful regulatory meetings • Authoring more than 60 protocols for various indication clinical trials • Development of procedures for medical services and pharmacovigilance department • Growing PVG department from 2 to 65 people and training more than 100 people in various processes • Successful completion of more than 20 global medical trials as medical lead • Software developments for Pharmacovigilance Case Processing, Remote Auditing, Pharmacovigilance System Master File and ICSR Tracking • Successful product launch and branding of oncology indication across 14 major cities of India • DCGI approval for 10 products for launch • USFDA approval of 26 products for launch Core Competencies • Medical & Regulatory Affairs • Medical Monitoring • Pharmacovigilance • Project & Program Management • Quality by Design • Medical Software Subject Matter Expert • Strategic Research & Development • Clinical Pharmacology • Medical & Scientific Writing • Proposals and Contracts • Team Management and Training • Business Development and Client Management • New Product Selection • NCE & NDDS Development • Biosimilars, Vaccines and Medical Devices