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Pfizer
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Associate - Safety Data Management Specialist

Associate - Safety Data Management Specialist

Pfizer

3 - 5 years

4 - 9 Lacs

Chennai

Posted:3 weeks ago| Platform:

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Skills Required

Data management XML Reconciliation Standard operating procedures Data collection Database Case processing Drug safety Data entry

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

Medical

#LI-PFE

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