TCS Careers India Hiring for Medical Reviewer

Medical Reviewer

 

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.

• 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.

Skills required:

· Computer Literate (good knowledge of MS Office)

· Sound understanding of the Drug Safety and Regulatory process

· Good problem solving and decision-making skills

· Capability to lead by motivation and example

· Ability to prioritize schedule and organize

· Excellent interpersonal and communication skills

Exp Range – 2 to 7 yrs

Locations – Mumbai, Pune, Delhi NCR and Bangalore

 

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