Labcorp job vacancy for Junior Safety Data Analyst- Apply Now
Junior Safety Data Analyst
Pune, India
Labcorp Drug Development
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com
The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.
Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to-
· Maintenance of adverse event tracking systems
· Set-up and maintenance of project files, and central files for documentation
· Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Labcorp project personnel, as required, within study specified timelines
· Ensure all incoming Adverse Event (AE)/ Serious Adverse Event (SAE) reports are appropriately logged into the departmental tracking application and forwarded to the centralized mailbox
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Assist with processing of the adverse events, including but not limited to:
· Data entry of safety data onto adverse event tracking systems
· Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable)
· Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)
· Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed
· Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Labcorp project personnel, as required within the agreed timelines
· Maintenance of adverse event tracking systems
· Assist with peer/quality review of processed reports and support with trends and actions as needed
· Assist in the reconciliation of databases, as applicable
· Assist in the maintenance of files regarding adverse event reporting requirements in all countries
· Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate
· Prepare and support coordination of safety study files for archiving at completion of projects
· Arrange and schedule internal and/or external meetings/teleconferences
· Train and mentor the PSS Assistants or peers in their day-to-day activities
· Build and maintain good PSS relationships across functional units
· Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans
· Assume responsibility for quality of data processed
· Provide administrative support to PSS personnel
· Any other duties as assigned by the management.
* The above job duties are completed by the staff as applicable, depending on the role they are assigned to.
