Associate – Safety Data Management Specialist

IND - Chennai Office, India

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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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Tags: Data management XML

Region: Asia/Pacific
Country: India

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