• 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.
· 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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