Safety Data Managment Associate
Pfizer Canada Inc.
Escazu, Costa Rica
hace 3 días

Primary Responsabilities

  • 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

    Technical Skill Requirements

  • 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 (required)
  • 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 English
  • 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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