- 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 Drug Safety database.

- Perform the following actions within the Comments field of the GSP Review Workflow step in the Drug 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 Safety System in Medical Review workflow.

- Ensure compliance with global and local procedural documents and local implementation of client, 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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