Medical Reviewer Job for MBBS at Tata Consultancy Services
Medical Reviewer Job for MBBS at Tata Consultancy Services, Hyderabad, India. Interested Candidates can check out the details below and Apply Online.
Job Role: Medical Reviewer
Job Company: Tata Consultancy Services
Job Location: Mumbai Metropolitan Region (On-site)
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.
Qualification: MBBS/MD (MCI Certification must)
Experience Required: 2 to 6 years experience in Medical reviewing/Drug safety