Associate II PSS - Dalian, 中国 - Fortrea

描述

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 solicited 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

o Determine listedness against appropriate label (for Marketed products, if applicable)

o Identifies clinically significant information missing from the reports and ensures its

collection; Prepare follow-up correspondence in consultation with the medical staff, as

needed

o Ensure case receives appropriate medical review

o Ensure all cases that require expediting reporting to worldwide regulatory agencies and

other required parties are processed swiftly and appropriately within required timelines

o Reporting of endpoints to clients, regulatory authorities, ethics committees,

investigators, 3rd party vendor, Partner and Labcorp project personnel, if required,

within study specified timelines

o Submission of expedited Serious Adverse Event (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 timelines

 Assist or contribute to Database reconciliation in liaison with Data Management team or clients

 Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and

submission, includes but not limited too Maintenance of adverse event 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

 Perform quality review or peer review of processed reports and support the Line Management with

trends and actions needed

 Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work

Instructions (WI), guidance documents and directives associated with safety management, reporting

and pharmacovigilance

 Assist in the generation and maintenance of the PSS metrics

 Support preparation for client meetings and liaise with clients where appropriate.

 Assist with the set-up of, and the provision of data to Safety Committees/DSMBs as applicable

 Prepare and support coordination of safety study files for archiving at completion of projects

 Support Root cause analysis and CAPA plan development for the identified quality issues, as needed

 Support and/or participate in audits and inspections including the preparation, as needed

 Demonstrate role-specific Core Competencies and company values on a consistent basis

 Build and maintain good PSS relationships across functional units

 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.