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Associate Safety Data Management Specialist

Pfizer
Pfizer
Freshers years
Preffered by Company
Not Disclosed May 13, 2024
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: ICSR Case Processing

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 Assessments:
    • Determine appropriate workflow for case processing
    • Assess cases for complexities and specific issues; escalate appropriately

 

Narrative and Follow-Up

  • Write and Edit Case Narrative
  • Determine and Perform Appropriate Case Follow-Up:
    • Generate follow-up requests

 

Case Review and Compliance

  • Review Processed Cases:
    • Verify accuracy, consistency, and compliance with process requirements
    • Review case data for special scenarios

 

Liaison and Expertise Development

  • Liaise with Key Partners:
    • Local partners and stakeholders
    • Safety data collection and data reconciliation
  • Develop and Maintain Expertise:
    • Corporate and global regulations
    • Guidelines and Standard Operating Procedures
    • Data entry conventions
    • Search functions in the safety database

 

Reportability and Regulatory Adherence

  • Determine Reportability of Scheduled Reports:
    • Ensure adherence to regulatory requirements
  • Apply Regulatory Requirements and Pfizer Policies Consistently

 

Participation in Safety Activities

  • Participate in Local, Internal, and External Safety Activities as Appropriate

 

Qualifications & Experience

Required

  • B. Pharm. / M.Pharm. / Pharm D graduates
  • 2-3 years of experience in ICSR case processing
  • Freshers with relevant skills are also eligible

Must Have

  • Meticulous attention to detail and accuracy
  • Good written communication skills
  • Analytical and problem-solving skills
  • Proficiency in medical terminology
  • Knowledge of ICSR processing guidelines and regulations

Nice to Have

  • Knowledge of event assessment
  • Working experience in the ARGUS database

 

Work Location Assignment

  • On-Premise

 

Additional Information

  • All elements of your compensation, including the value of non-monetary perquisites, will be subject to deduction of applicable tax at source, as required by the Income-tax Act, 1961.
  • Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.