Shabin Taj
Clinician, Senior Medical Advisor with experience in Drug Research, Clinical Trials and Medical Monitoring
- Role
- Medical Advisor at IQVIA
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shabin Taj
Total experience of 13 plus years as a Clinician in various positions and various…
Experience
Medical Advisor
May 2019 — Present · Bangalore, IN
Provide medical expertise, advice and guidance to members of the clinical development project teams• Design clinical studies to meet the requirements outlined in the Target Product Profile• Provide global medical input into country feasibility• Coordinate with sponsor Clinical Scientist to review and approve design deliverables• Draft and review study-specific medical monitoring plans• Document all medical monitoring activities and communications related to the study• Manage SAEs - review SAEs that occur during studies as and to assist in identifying any emergent safety concerns that may be related to study conduct• Support SAE reporting and notifications to Ethics Committees and Health Authorities• Review clinical and safety data for trends • Provide support for urgent medical enquiries to sites across the study • Medical review of data listings• Reviews individual data with SAEs and clinically important laboratory test or vital sign abnormalities• Draft and Review all patients’ narratives• Contribute to and review clinical study reports• Deliver protocol, therapeutic and safety training during Investigator meeting at the study level• Train study monitoring team on the protocol and safety reporting• Support with the Ministry of Health Interaction• Accountable for providing a response to regulatory agency inspection observations and internal audits
Education
Rajiv Gandhi University of Health Sciences
Master's degree, MD
Rajiv Gandhi University of Health Sciences
Bachelor's degree
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