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Associate Safety Data Management Specialist

Freshers years
Preffered by Company
Not Disclosed May 13, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: ICSR Case Processing

Associate - Safety Data Management Specialist

Application Information

  • Locations: India - Chennai
  • Time Type: Full-time
  • Posted On: Posted 2 Days Ago
  • Job Requisition ID: 4908042

 

Job Responsibilities

Case Processing Activities

  • Review, rank, verify, process, and document case-related information, including:
    • Event terms
    • Validity
    • Seriousness
    • Special scenarios
    • Timelines
    • Accuracy and consistency
  • Process cases based on these assessments
  • Review case criteria to determine the appropriate workflow for case processing
  • Assess cases to identify complexities and specific issues, escalating appropriately
  • Write and edit case narratives
  • Determine and perform appropriate case follow-up, including generating follow-up requests
  • Review processed cases to verify accuracy, consistency, and compliance with process requirements; review case data for special scenarios

Liaison and Expertise Development

  • Liaise with key local partners and stakeholders regarding safety data collection and data reconciliation
  • Develop and maintain expertise and knowledge for applicable corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and search functions in the safety database

Reportability and Regulatory Adherence

  • Determine the reportability of scheduled reports, ensuring adherence to regulatory requirements
  • Consistently apply regulatory requirements and Pfizer policies

Participation in Safety Activities

  • Participate, as appropriate, in local, internal, and external safety activities

 

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
  • Proficient 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.