Category Archives: Case Evaluator

Case Evaluator

Function

Evaluation of SAE cases following the L2 path (all serious, legal, interventional studies, pregnancies) in accordance with regulatory requirements for AE reporting.

Determination of seriousness, drug product association and global labeling status (expected vs. unexpected) in order to assign the appropriate case reporting status for global distribution of regulatory case reports.

Addition of PSUR comments to individual case safety reports to facilitate PSUR authoring.

Execution of a high-quality, accurate and timely SAE case evaluation process within a therapeutic area and contribution to continuous improvement of PV system and processes.

Confirmation of the accuracy of medical coding of all SAE and drug terms (MedDRA and WHO-DD).

Verification of SAE case evaluation within area of responsibility for conformity with the project’s SOPs and operational manuals.

Determination of the completeness of single case reports as to medical content, clarification of inconsistent information, and requisition of required additional information from the project’s affiliates and/or subcontractors.

Participation in the review of the project’s AE/SAE reporting compliance.

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