Assistant I Pss

3 days ago

Pune, India Fortrea Full time

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

 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 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 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.

For more information about how we collect and store your personal data, please see our

Privacy Statement

.

  • Asst I Pss

    2 weeks ago

    Pune, Maharashtra, India Fortrea Full time

    **Job Overview**: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to...

  • Assistant II PSS

    6 days ago

    Pune, Maharashtra, India Fortrea Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    Job Overview:Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the...

  • Spec I Pss

    1 week ago

    Pune, India Labcorp Full time

    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: - 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...

  • Safety Science Coordinator I

    4 days ago

    Pune, Maharashtra, India Fortrea Full time ₹ 5,00,000 - ₹ 8,00,000 per year

    Job OverviewAssist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the...

  • Safety Science Coordinator I

    2 weeks ago

    Pune, Maharashtra, India Fortrea Full time

    **Job Overview**: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to...

  • Safety Science Coordinator I

    2 weeks ago

    Pune, Maharashtra, India Fortrea Full time

    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...

  • Assistant Manager- E&i

    2 days ago

    Pune, Maharashtra, India Ingersoll Rand Full time

    Ingersoll Rand is committed to achieving workforce diversity reflective of our communities We are an equal opportunity employer All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin...

  • Client Support Specialist I

    2 weeks ago

    Pune, Maharashtra, India ICE Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job DescriptionJob PurposeThe Client Support Specialist I acts as a subject-matter and product-area specialist to provide support to our customer base utilizing Simplifile products, services, platform technologies, and workflows. As an escalation point, the Client Support Specialist I endeavors to deliver complete resolutions in a timely and consistent...

  • Client Support Specialist I

    2 weeks ago

    Pune, Maharashtra, India ICE Data Services Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    Job PurposeThe Client Support Specialist I acts as a subject-matter and product-area specialist to provide support to our customer base utilizing Simplifile products, services, platform technologies, and workflows. As an escalation point, the Client Support Specialist I endeavors to deliver complete resolutions in a timely and consistent manner to address...

  • Clinical Trial Assistant- I

    3 days ago

    Karve Nagar, Pune, Maharashtra, India ProRelix Research Full time

    **Immediate Joiner** **Job Summary**: We are seeking a highly motivated and detail-oriented Clinical Trial Assistant (CTA) - I to join our clinical operations team. The CTA will support the execution of clinical trials by providing administrative and coordination assistance. This is an entry-level position ideal for recent graduates or those with up to 6...