Medical Reviewer

6 months ago


Mumbai, India Tata Consultancy Services Full time

TCS is hiring for MBBS/MD professionals

**Role**: Medical Reviewer

**Experience Range**: 1 to 7 Years

**Qualification**: MBBS/MD only
- 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.
- Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff.


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