Drug Safety Unit
- Safety Data
Management Specialist

ROLE SUMMARY

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.

ROLE 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

• Bachelor's Degree
• Fluency in Korean & English is required (both speaking & writing)
• 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
• 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
• Preferred 1 to 2 years experiences in pharmacovigilance or clinical research