Spec Ii Pss

Assist in the processing of expedited safety reports (ESRs). This includes, but is not limited to: - maintenance of adverse event tracking systems - set-up and maintenance of project files, core process files and central safety files - reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if...

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...

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...

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 patient...

Ensuring that the IST investigator is providing study updates as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent. - Regular follow up with the customer POCs for updates on the...

Ensuring that the IST investigator is providing study updates as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent. - Regular follow up with the customer POCs for updates on the...

Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating proceduresEnsure compliance of operations with governing regulatory requirementsCreate, maintain and assume accountability for a culture of high customer serviceExecute drug safety data management processes - a combination...

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...

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...

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...

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...

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...

Ensuring that the IST investigator is providing study updates in tool as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent. - Reviewing that the agreed upon contractual milestones are...

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...

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...

Ensuring that the IST investigator is providing study updates in a client tool as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent. - Reviewing that the agreed upon contractual...

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...

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...

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 multiple...

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...