– 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.