Medical Reviewer

Job Code # 47

Job Location-  Mumbai

Salary- 15 LPA to 25 LPA

Key skills-
a) Minimum 1 year of experience in PV/ Clinical Research (drug safety)
b) MBBS/MD is must

Job Description-
• Minimum of 1-5 years of experience in PV/ Clinical Research (drug safety)
• 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
• 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