Medical Reviewer

Medical Reviewer

Golden Opportunities Private Limited
Mumbai Pune
0 - 1 Years
Not Specified

Job Description

Medical Reviewer


Job Location: Mumbai & Pune

Job Description:
Major Deliverables:- Case Evaluation
1. Evaluation of SAE cases following the L2 path (all serious legal interventional studies pregnancies) in accordance with regulatory requirements for AE reporting.
2. 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.
3. 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.
4. Confirmation of the accuracy of medical coding of all SAE and drug terms (MedDRA and WHO-DD).

Golden Opportunities Pvt. Ltd

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