Tata Consultancy Services jobs - Medical reviewer

Qualicifacion :

MBBS with min 3years experience in Medical reviewing

OR

MD with 0 to 1 year experience in Medical reviewing

JD

•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.