Bharat Sharma

A transformational, decisive, strategic & high energy driven professional with total 12 years of experience, and current experience of 5 years in Pharmacovigilance. Striving for challenging assignments in Clinical Research, Pharmacovigilance Functions and Medical Reporting & Documentation.

• A focused & keen Drug Safety Physician with domain experience of the Pharmaceutical or CRO (Contract Research Organizations) industry, having expertise in Clinical Research/ Studies
• Skilled at adhering to guidelines & regulations in Clinical Research, Pharmacovigilance with strong working knowledge of various Medical Terminologies, ICMR & ICH Regulations, GCP Understandings, ICSRs, GVP Modules/ New EU PV Legislation, FDA Guideline, and CIOMS
• Proficient in multiple therapeutic areas and across multiple phases of clinical trials; proficient in MedDRA coding by "MedDRA Term Selection: Points to Consider"
• Wealth of expertise entaild verifying SOP-s, conducting clinical trials, processing & reporting on adverse event program, following up crucial case reports, collecting and validating adverse reports and preparing safety reports
• Expertise in the assessment of cases for Important Medical Events (IMEs), ensuring the completeness, accuracy and consistency of the data so that it meets the standards required for reporting to regulatory bodies
• Experienced in reviewing literature articles for detecting potential safety signals within the portfolio of Translational Clinical Oncology (TCO)
• Comprehensive knowledge of safety databases, different safety case processing and surveillance management systems, along with proficiency in SAP-ERP, Microsoft Office, Internet Applications
• Proficient in independently monitoring visits at the investigative sites including reviewing case report forms (CRFs), performing source document verification, monitoring compliance with Good Clinical Practice (GCP) guidelines and FDA regulations
• Proven capability to make timely and well-reasoned decisions based on an insightful analysis of all critical information; capability to balance analysis with decisiveness
• Skilled in reviewing & training on Standard Operating Procedures (SOPs) and work instruction for conducting clinical trial
• An effective communicator with honed interpersonal, analytical and problem-solving skills; proven aptitude to cultivate relationships with co-workers in a cross-functional environment

 · “Medically significant hypersensitivity reaction to dapsone: A case report” International healthcare research journal ,april 2018, volume2, issue 1

· “Pulmonary mucormycosis with diabetes mellitus: a case report”. International healthcare research journal, 2018 volume2(2); 33-34