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Private Jobs / Private Sector
Fortrea Hiring for Associate 1 PSS at Pune, Maharashtra Full Time
Full Job Description
Process the adverse event reports from any source as per client/sponsor agreed plans
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
o Data entry of safety data onto adverse event database(s) and tracking systems
o Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
o Write patient narratives & code adverse events accurately using MedDRA, if applicable
o Determine listedness against appropriate label (for Marketed products, if applicable)
o Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed
o Ensure case receives appropriate medical review
o Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines
o Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Labcorp project personnel, if required & as agreed with client during study set-up, within study specified timelinesPerform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to-
o Maintenance of tracking systems
o Set-up and maintenance of project files and central files for documentation
o Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Labcorp project personnel, as required, within study specified timelines
Support with quality review or peer review of the processed reports
Assist and/or complete the database reconciliation and the associated activities, as applicable
Maintain study/project level documentation as per the agreed requirements, as applicable
Support with training of PSS staff and mentor the team as needed
Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed)
Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting and pharmacovigilance
Assist in the preparation for client meetings and liaise with client contacts, where appropriate
Assist in Quality issues management and support audit and inspection preparation, as needed
Ensure compliance of operations with governing regulatory requirements and applicable study/project plans, and take responsibility for quality of data processed
Assist in the preparation of client meetings and liaise with clients where appropriate
Any other duties as assigned by management.
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
o Data entry of safety data onto adverse event database(s) and tracking systems
o Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
o Write patient narratives & code adverse events accurately using MedDRA, if applicable
o Determine listedness against appropriate label (for Marketed products, if applicable)
o Identifies clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed
o Ensure case receives appropriate medical review
o Ensure all cases that require expediting reporting to worldwide regulatory agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines
o Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Labcorp project personnel, if required & as agreed with client during study set-up, within study specified timelinesPerform processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to-
o Maintenance of tracking systems
o Set-up and maintenance of project files and central files for documentation
o Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Labcorp project personnel, as required, within study specified timelines
Support with quality review or peer review of the processed reports
Assist and/or complete the database reconciliation and the associated activities, as applicable
Maintain study/project level documentation as per the agreed requirements, as applicable
Support with training of PSS staff and mentor the team as needed
Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed)
Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance/ procedural documents and directives associated with safety management, reporting and pharmacovigilance
Assist in the preparation for client meetings and liaise with client contacts, where appropriate
Assist in Quality issues management and support audit and inspection preparation, as needed
Ensure compliance of operations with governing regulatory requirements and applicable study/project plans, and take responsibility for quality of data processed
Assist in the preparation of client meetings and liaise with clients where appropriate
Any other duties as assigned by management.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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