Pfizer Pharma Associate Job Openings – Safety Data Management Role

Associate – Safety Data Management Specialist

Locations: India – Chennai

Time Type: Full time

Posted on: Posted 2 Days Ago

Job Requisition ID: 4908042

Job 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, guidelines, Standard Operating Procedures, data entry conventions, and 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.

Qualification & Experience:

B. Pharm./ M.Pharm. / Pharm D graduates with 2-3 years of experience in ICSR case processing.

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 ARGUS database.

Work Location Assignment: On Premise

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