Associate – Safety Data Management Specialist

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 

Here Is What You Need (Minimum Requirements):

• Education = B. Pharm, M. Pharm, or Pharm. D only.
• Minimum experience = 1 year. Maximum = 2 years.
• End to End ICSR processing, including listedness assessment.
• Ability to work collaboratively in a team environment.

Bonus Points If You Have (Preferred Requirements):

• Hands on experience in ARGUS safety database.
• Proficiency with processing source documents in XML format (E2B R2 and R3).
• Good knowledge of medical terminology and global regulatory requirements for drug safety.

  
Work Location Assignment: Hybrid

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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