Location
Pune | India
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.
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
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
FOR GLOBAL REWARDS USE ONLY: Template Updated – June 2021 Page 3 of 5
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.
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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