Safety Data Management Specialist

Descrizione : Safety Data Management Specialist. Azienda : Pfizer. Posizione : Roma, Lazio

*11 months temporary contract

Position Purpose

  • Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.
  • Determination of local submission of individual and, where appropriate, aggregate safety reports.

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.


  • Scientific Degree
  • Experience in pharmacovigilance and/or data management preferred
  • Health Care Professional or equivalent experience preferred
  • Experience and skills with medical writing (an advantage)
  • Demonstrated computer literacy
  • Fluency in spoken and written English
  • Experience in use and management of relational databases 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

Dealine to apply: April 8th


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