WRDC-GO DSU-Associate I, Safety Data Management Specialist
Pfizer
Wuhan R&D Center, HB , CHN
5天前

WRDC-GO DSU-Associate I, Safety Data Management Specialist

  • CHN - HB - Wuhan R&D Center
  • 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 the appropriate workflow for case processing
  • Assess cases to distinguish those with particular complexities and / or specific issues, and escalate appropriately
  • Write and edit the 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
  • Experience in pharmacovigilance and / or data management preferred but not required
  • Experience and skill with medical writing an advantage
  • Demonstrated computer literacy
  • Experience in use and management of relational databases preferred
  • Health Care Professional or equivalent experience 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
  • Fluency in spoken and written EnglishCarry 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 assessmentsReview case criteria to determine the appropriate workflow for case processingAssess cases to distinguish those with particular complexities and / or specific issues, and escalate appropriatelyWrite and edit the case narrativeDetermine and perform appropriate case follow-up, including generation of follow-up requestsReview processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenariosLiaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliationDevelop 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 databaseDetermine reportability of scheduled reports , ensuring adherence to regulatory requirementsConsistently apply regulatory requirements and Pfizer policiesParticipate, as appropriate, in local, internal and external safety activitiesN : Not Applicable - 不适用 (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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