Role: - Medical Reviewer

Work Location: Chennai/Indore/Mumbai/Pune/Gandhinagar

Educational Qualifications: - MBBS/MD only

Job description:

•         Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR).

•         Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. 

•         Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database:

-Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database.  

-Detail any requests for changes to the case, including the narrative.

-Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database.

•         Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). 

•         Review the company causality assessment provided by Medical Advisor.

•         Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. 

•         To provide documentation of the review and case comments in Sapphire in Medical Review workflow.

•         Ensure compliance with global and local procedural documents and local implementation of client and TCS, policies, procedures and processes.

•        Maintain knowledge of the marketed drug currently under litigation.

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