
Medical Reviewer
4 days ago
Role -Medical Reviewer
Qualification: MBBS/MD only (MCI Certification is not mandate**)
Experience Range: 1 to 7 Years
Preferred Experience: Minimum of 1-5 years of experience in PV/ Clinical Research (drug safety)
Location: Mumbai/ Pune/ Nagpur/ Gandhinagar/ Bangalore/ Chennai/ Indore.
Roles & Responsibilities
- 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.
- 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.
**Job Types**: Full-time, Fresher
**Salary**: Up to ₹1,500,000.00 per year
Schedule:
- Rotational shift
**Experience**:
- Medical Reviewer: 5 years (preferred)
Work Location: In person
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