Safety Science Coordinator II

Fortrea

3mo ago

Job
Full-time
Mid & Senior Level
Data
Research & Development
Pune
Quick Apply

AI generated summary

You must manage adverse event reports, ensure data accuracy, write narratives, support reporting, mentor staff, and understand safety protocols and regulations in pharmacovigilance.
You will manage adverse event reports, ensure accurate data processing, assist with regulatory submissions, support safety database maintenance, and mentor junior staff in case handling.

Requirements

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
Data entry of safety data onto adverse event database(s) and tracking systems.
Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.
Write patient narratives and code adverse events accurately using MedDRA.
Determine listedness against appropriate label (for Marketed products, if applicable).
Identifies clinically significant information missing from the reports and ensures its collection and follow-up.
Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines.
Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines.
Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines.
Perform Database reconciliation with Data Management team or sponsor/client as needed.
Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), 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 Fortrea project personnel, as required, within study specified timelines.
Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate.
Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed.
Begin participating in signal detection and trend & pattern recognition activities, as appropriate.
Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc.
Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting
Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
Participate in Fortrea project team and client meetings, as appropriate.
Prepare and support coordination of safety study files for archiving at completion of projects.
Contribute to root cause analysis, including the CAPA plan development & implementation.
Support Audits and/or inspections preparation
Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees.
All other duties as needed or assigned.

Responsibilities

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:
Data entry of safety data onto adverse event database(s) and tracking systems.
Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.
Write patient narratives and code adverse events accurately using MedDRA.
Determine listedness against appropriate label (for Marketed products, if applicable).
Identifies clinically significant information missing from the reports and ensures its collection and follow-up.
Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines.
Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines.
Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines.
Perform Database reconciliation with Data Management team or sponsor/client as needed.
Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), 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 Fortrea project personnel, as required, within study specified timelines.
Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate.
Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed.
Begin participating in signal detection and trend & pattern recognition activities, as appropriate.
Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc.
Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting
Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
Participate in Fortrea project team and client meetings, as appropriate.
Prepare and support coordination of safety study files for archiving at completion of projects.
Contribute to root cause analysis, including the CAPA plan development & implementation.
Support Audits and/or inspections preparation
Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees.
All other duties as needed or assigned.

FAQs

What is the main responsibility of a Safety Science Coordinator II?

The main responsibility of a Safety Science Coordinator II is to manage the receipt and processing of adverse event reports, ensuring their accurate entry, review, and reporting within required timelines.

What kind of reports will I be handling in this role?

In this role, you will handle adverse event reports, expedited Serious Adverse Event (SAE) reports, and Periodic Safety Reports (PSRs), among others.

Is knowledge of MedDRA coding necessary for this position?

Yes, accurate coding of adverse events using MedDRA is a required task for the Safety Science Coordinator II position.

Will I need to contribute to safety data analysis?

Yes, you will begin participating in signal detection and trend & pattern recognition activities as appropriate.

Is there a requirement to assist or mentor less experienced staff?

Yes, part of the role includes supporting, training, and mentoring less experienced safety staff in all aspects of case-handling and adverse event reporting.

Will I be involved in the preparation of regulatory documents?

Yes, you will assist in the preparation of various reports such as Annual IND reports and Periodic Safety Update Reports (PSURs).

What is the team dynamic at Fortrea?

Fortrea promotes a collaborative workspace where personal growth is nurtured, allowing team members to make a meaningful global impact.

Are there opportunities for professional development within this position?

Yes, the role supports personal growth and offers opportunities for professional development through training and involvement in various safety management activities.

What are the company values regarding diversity and inclusion?

Fortrea is committed to diversity and inclusion within the workforce and does not tolerate harassment or discrimination of any kind.

Is experience required for this role?

While specific experience may be preferred, the role seeks motivated problem-solvers and creative thinkers who are passionate about clinical trials.

Fortrea

Science & Healthcare

Industry

10,001+

Employees

2023

Founded Year

Mission & Purpose

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.