Vasanth Kumar Email & Phone Number

Bengaluru, Karnataka, India

• Perform medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions including narrative content, queries, coding, expectedness, seriousness, causality, and company summary/Medical assessment comment as applicable.• Medical evaluation of ICSR including but not limited to all serious, non-serious line listings, expedited reports and all pregnancy reports.• Identifying safety signals, DMEs, watch list events and events of special interest during ICSR review and non-serious line listing review and notification to the client.• Understanding on the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract.• Act as Global Safety Physician/Assistant or Back-up on projects as assigned.• Attend project meetings, medical safety team meetings, and client meetings as requested.• Provide medical escalation support for medical information projects.

Bengaluru South, Karnataka, India

• Review of SOPs for regulatory compliance & feasibility of implementation.• To ensure protocols are reviewed for scientific soundness, regulatory and SOP compliance.• Identify resources required for the smooth functioning of the clinical department including infrastructure, manpower and systems; also ensure that these follow regulatory requirements. Ensure that all personnel in the clinical department are trained in GCP, relevant SOPs and relevant job specific procedures.• Review AEs and SAEs with Investigators.• Ensure the rights & well-being of study subjects are safeguarded in coordination with ethics committees.• Facilitate client audits and ensure appropriate resolution of client and regulatory queries.• Follow up of revision of SOPs with relevant personnel and to ensure SOPs are revised on time.• Timely review and resolution of audit reports with relevant personnel.

Bengaluru, Karnataka, India

• Review of SOPs for regulatory compliance & feasibility of implementation.• To ensure protocols are reviewed for scientific soundness, regulatory and SOP compliance.• Identify resources required for the smooth functioning of the clinical department including infrastructure, manpower and systems; also ensure that these follow regulatory requirements.• Ensure that all personnel in the clinical department are trained in GCP, relevant SOPs and relevant job specific procedures.• Review AEs and SAEs with Investigators.• Ensure the rights & well-being of study subjects are safeguarded in coordination with ethics committees.• Facilitate client audits and ensure appropriate resolution of client and regulatory queries.• Follow up of revision of SOPs with relevant personnel and to ensure SOPs are revised on time.• Timely review and resolution of audit reports with relevant personnel.

Bengaluru, Karnataka, India

• Review of SOPs for regulatory compliance & feasibility of implementation.• To ensure protocols are reviewed for scientific soundness, regulatory and SOP compliance.• Identify resources required for the smooth functioning of the clinical department including infrastructure, manpower and systems; also ensure that these follow regulatory requirements.• Ensure that all personnel in the clinical department are trained in GCP, relevant SOPs and relevant job specific procedures.• Review AEs and SAEs with Investigators.• Ensure the rights & well-being of study subjects are safeguarded in coordination with ethics committees.• Facilitate client audits and ensure appropriate resolution of client and regulatory queries.• Follow up of revision of SOPs with relevant personnel and to ensure SOPs are revised on time.• Timely review and resolution of audit reports with relevant personnel.

Bengaluru, Karnataka, India

• Perform General Physical examination and systemic examination of the patients.• Review of Lab reports, ECG and treat the patients on case-to-case basis.

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bachelor Of Medicine, Bachelor Of Surgery - Mbbs

Education record