Fortrea Safety Science Coordinator I job vacancy at Pune India
Safety Science Coordinator I
Pune India
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Data entry of safety data onto adverse event tracking systems
o Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable)
o Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)
o Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed
o 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
o 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.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
