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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...

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...

**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...

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...

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

JOB FAMILY SUMMARY: Administrative Support provides a wide variety of office support and administrative functions in support of the department and/or leader. Requires proficiency in the full range of general office services and functions as well as knowledge of the services of their department and work assignments while handling details that may be...

Execute drug safety data management processes - a combination of call intake, case intake, triage, case entry, medical coding, narrative writing, peer review, case follow - up. Perform any other support activities as assigned - tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from...

Master’s degree in Pharmacy/related science area - Bachelor’s degree in Medical Science - At least 5 years’ experience in the pharmaceutical industry, with at least 3 years of it in medical writing - Experience in drug discovery and pharmacovigilance is desirable - Write various safety reports (or part of such reports) for global regulatory submissions...

Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures - Ensure compliance of operations with governing regulatory requirements - Create, maintain and assume accountability for a culture of high customer service Operational - Execute drug safety data management...

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...