Arpan Mishra

Safety Science Analyst

Labcorp•  August 2020 - Present

• Assist in the processing and reporting of expedited safety reports (ESRs) to Clients, Regulatory Authorities, Ethics Committees, Investigators and Covance Project Personnel. • Maintenance of Adverse Event tracking systems. • Set-up and maintenance of project files, core process files and central safety files. • Ensure all incoming faxed Serious Adverse Events reports are appropriately stamped, logged into the departmental tracking application and forwarded in timely manner to the designated Drug Safety Associate (DSA)/Senior Drug Safety Associate (Sr. DSA). • Work within the Standard Operating Procedure system, including departmental Work Instructions. • Assist in maintenance of files regarding adverse event reporting requirements in all countries. • Provide administrative support to Patient Safety Solutions & Adjudication (PSS&A) personnel. • Maintain and distribute a weekly schedule for Patient Safety Solutions & Adjudication (PSS&A) staff. • Ensure submission of client-related documents is sent to the client within designated timeframes. • Assist the Drug Safety Associate/Senior Drug Safety Associate in preparation of materials needed for client and/or investigator meetings.

Drug safety Intern

Labcorp•  January 2020 - July 2020

• Operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s) • Assist in the processing of adjudication events. This includes, but is not limited to Maintaining event tracking systems, Event case processing (tracking, data entry, document processing like redaction pf specified content) • Assist with the coordination of adjudication meetings. This includes, but is not limited to copying and distributing meeting materials • Assist with the processing of adjudicator payments. This includes, but is not limited to receiving and tracking adjudicator invoices, preparing payment requests for review and approval, tracking payments issued • Assist with file maintenance which includes and is not limited to set-up, maintenance and archiving of project and event files • Provide administrative support to Adjudication Services personnel. This includes and is not limited to word processing, proof-reading, editing documents, handling photocopying, mailing, faxing, scanning of documents • Work in accordance with the Standard Operating Procedure (SOP) system, including department Work Instructions (WIs) • Build and maintain good working relationships within Adjudication Services Department • Any other duties as assigned by management.

Clinical Research Coordinator Intern

Manipal Hospital•  March 2019 - April 2019

Under the guidance of the senior clinical research coordinator learned procedures for preparation of templates of various documents involved in the clinical research trial site. The documents and processes I was involved in are as follows: • Ethics and Scientific Committee Submission • Endorsement sheet preparation • Clinical trial Budget • Feasibility Questionnaire fill up