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Associate - Safety Data Management Specialist @ Pfizer

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 Associate - Safety Data Management Specialist

Job Description

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, 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. Qualification & Experience: B. Pharm. / M. Pharm. / Pharm D graduates with 2-3 years of experience in the relevant area

Must have:

Good knowledge of ICSR processing guidelines

Attention to detail

Nice to have:

  • ARGUS database experience of minimum 6 months.
  • Knowledge of medical assessment

Job Classification

Industry: Pharmaceutical & Life Sciences
Functional Area: Pharmaceutical & Life Sciences
Role Category: Administration
Role: Vendor Management
Employement Type: Full time

Contact Details:

Company: Pfizer
Location(s): Chennai

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Keyskills:   Data management Data olletion Reoniliation Database Compliane Standard operating proedures Data entry Case proessing

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₹ -6 Lacs P.A

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Pfizer

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