Pfizer Safety Data Managment Specialist in Escazu, Costa Rica

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

Qualifications

  • 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.