Clinical Trial Hub Safety Associate

职位概述：

• ·Review, preparation, and completion of clinical study and compassionate use sourced adverse event (AE)/serious adverse event (SAE) reports, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.

• Determination of local submission of individual and, where appropriate, aggregate safety reports.

工作职责：

• Carry out case book-in, data entry and processing activities.

• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.

• Identify and select cases for data entry, determining appropriate prioritization criteria, and noting reasons for any delays.

• Review, rank, process and document case-related information: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness), special scenarios, product complaint information, reportability with due date; and accuracy and consistency.  Based on case assessment, forward the case to the appropriate workflow.

• Write and edit the case narrative.

• Consistently apply regulatory requirements and Pfizer policies to determine reportability of scheduled reports, generate reports, and ensure adherence to regulatory compliance timelines.

• Determine and perform appropriate case follow-up, including generation of follow-up request letters when appropriate.

• Liaise with key partners, including Global Pharmacovigilance Organization, Pfizer Safety Surveillance and Reporting Centers of Excellence, Clinical Development, License Partners, and other stakeholders regarding clinical study and compassionate use sourced AE/SAE collection, data reconciliation, and AE/SAE distribution/submission.  Participate, as appropriate, internal and external safety activities.

• Develop and maintain expertise and knowledge of all products within the Pfizer portfolio, applicable corporate and global regulations, guidelines, Standard Operating Procedures and written practices, data entry conventions, and search functions in the safety database.

任职资格：

• Bachelor’s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.

• Ability, with supervision, to solve routine problems and to surface issues constructively.

• Ability to make basic decisions with an understanding of the consequences. 

• Ability to achieve personal objectives while meeting departmental standards of performance

• Ability to work under supervision in a matrix organization