Offer summary

Qualifications:

Medical degree with specialization in relevant field., Experience in medical safety and case review processes., Strong understanding of adverse event coding and regulatory compliance., Excellent communication and training skills..

Key responsibilities:

Conduct primary medical reviews of cases for seriousness and causality.

Document and update case data in tracking tools for workflow management.

Ensure all deliverables meet quality and compliance standards.

Provide training to the case processing team after one year of tenure.

Job description

Job Overview:

Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.

Summary of Responsibilities:

Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review.
Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.
Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year.
Performs aggregate and signal analysis activities, as required in support of single case processing.
Creates, maintains, and assumes accountability for a culture of high customer service.

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