Safety Data Management Specialist
Pfizer
Escazu, Costa Rica
hace 20 horas

Safety Data Management Specialist

  • Costa Rica - Escazu
  • Primary Responsibilities

  • Carry out case processing activitiesReview, 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 appropriate workflow for case processingAssess cases to distinguish those with particular complexities and / or specific issues, and escalate appropriatelyWrite and edit 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 activities

    Technical Skill Requirements

    Experience in pharmacovigilance and / or data management preferred but not requiredExperience and skill with medical writing an advantageDemonstrated computer literacyExperience in use and management of relational databases preferred

    Qualifications

    Health Care Professional is requiredAbility, with supervision, to solve routine problems and to surface issues constructivelyAbility to make basic decisions with an understanding of the consequencesAbility to achieve personal objectives while meeting departmental standards of performanceAbility to work under supervision in a matrix organizationFluency in spoken and written English is required

    LI-PFE

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

    Medical

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