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Associate I, Safety Assessment


Shanghai, R&d Center
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Job Details

**Position Purpose**

+ Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements.

**Primary Responsibilities**

+ Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.

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

+ Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.

+ Review case criteria to determine the appropriate workflow for case processing.

+ Write and edit the case narrative.

+ Generate reports, ensuring adherence to regulatory compliance timelines.

+ Determine appropriate case follow-up, requesting follow-up letters when appropriate.

+ Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.

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

+ Consistently apply regulatory requirements and Pfizer policies.

**Technical Skill Requirements**

+ Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.

+ Demonstrated computer literacy, particularly in the use and management of relational databases.

+ Ability to achieve personal objectives while meeting departmental standards of performance.

+ Ability to work under supervision in a matrix organization.

+ Excellent oral and written communication skills.

+ Fluency in spoken and written English; knowledge of additional language(s) an advantage.

+ Experience and skill with medical writing an advantage.

N: Not Applicable - (China)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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