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Location

Pune | India

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Job description

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.

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 Cuthorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines

 Maintain a strong understanding of Fortrea 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

 Any other duties as assigned by management.

• The above job duties are completed by the staff as applicable, depending on the role they are assigned to.

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. For more information about Fortrea, visit

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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