23 days old

Safety Data Management Specialist

Pfizer
Hospira
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**Primary Responsibilities**



+ Carry out case processing activities

+ Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments

+ Review case criteria to determine appropriate workflow for case processing

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

+ Write and edit case narrative

+ Determine and perform appropriate case follow-up, including generation of follow-up requests

+ Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

+ Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation

+ Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database

+ Determine reportability of scheduled reports , ensuring adherence to regulatory requirements

+ Consistently apply regulatory requirements and Pfizer policies

+ Participate, as appropriate, in local, internal and external safety activities



**Education:**

B.Pharm, M.Pharm, Pharm. D, and Life Science Graduates. Post-graduation is an added advantage.

**Experience:**

Pharmacovigilance, Individual Case Safety Reports processing. Knowledge of ARGUS database preferable. Min exp: 0 years Max exp: 1.5 year.



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



Medical
Posted: 2020-03-05 Expires: 2020-04-05

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Safety Data Management Specialist

Pfizer
Hospira

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