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Dernière mise à jour : il y a plus de 30 jours
Data Reviewer

Data Reviewer

SUN PHARMANew Brunswick
19,50 $CA par heure
The Data Reviewer, Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the revi...Voir plusDernière mise à jour : il y a plus de 30 jours
Professionnels de l'information sur la santé 2

Professionnels de l'information sur la santé 2

Vitalité Health NetworkCampbellton, Nouveau-Brunswick
28,10 $CA –34,35 $CA par heure
Sous l’autorité du gestionnaire de l’Accueil, de l’Admission et des Archives cliniques, la personne titulaire du poste effectue toutes les tâches techniques de niveau avancé qui se rapportent à la ...Voir plusDernière mise à jour : il y a plus de 30 jours
Data Reviewer

Data Reviewer

SUN PHARMANew Brunswick
Il y a plus de 30 jours
Salaire
19,50 $CA par heure
Description de poste

The Data Reviewer, Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission applications by using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.

Area Of Responsibility

  • Ensures compliance with cGMP / cGLP and good documentation procedure during the review process
  • Audits regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist
  • Communicates any audit comments / observations / findings to respective stakeholders and assesses acceptability / appropriateness of responses
  • Informs the manager / s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity
  • Reports all audit finding in the ODR audit worksheets and highlight noteworthy / major / critical observations on CDRO certifications
  • Completes the audit tasks within the specified timeframe without compromising the quality of the audit and archives all documents in a closed electronic system
  • Collates audit findings in the audit comments log
  • Performs any other responsibilities which are required as assigned by the manager / s depending on departmental needs
  • Completes all training requirements as per Learning Management System (LMS) and as per Safety
  • Adheres to the Safety and Health Program and associated plans.

Work Conditions :

Corporate office environment

Laboratory environment – QC and ARD

Manufacturing / Production environment

The ODR data reviewer will be mainly working in an office environment as the job requires review of copies of reference documents. Exposure to laboratory / manufacturing environments is at a minimum only and only expected when the ODR data reviewer needs to physically view any concerns or needs to have a face-to-face discussion with the stakeholders.

Physical Requirements :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • In performance of his / her tasks, the ODR data reviewer should have the ability to sit at his / her desk for long periods of time, work on the computer for the majority of his / her work hours.
  • If needed, he / she must have the ability to navigate office, lab, and / or plant floor working environments while adhering to safety protocols.
  • He / she must have the ability to wear applicable personal protective equipment utilized at the site, as required in a specific location / section of the plant, including but not limited to respirators, safety glasses / goggles, and safety shoes.

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