Job Skill: Medical Review
Designation: Career Level - 11-Analyst
Job Location: Bengaluru
Qualifications: Any Graduation
Years of Experience: 3-5 years
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You will be aligned with our Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.
You will be working as a part of CDM - Clinical Data Management team which is responsible for the completeness and validity of the data in the clinical database. They review and resolve discrepancies identified by the system or through manual checks as per guidelines. Issue data clarification forms as and when required. Perform discrepancy review and perform Self-Evident Corrections per DRP (as and when required). Perform discrepancy management for SAE related discrepancies.
You will be responsible for Medical Review where in you will be responsible for the medical review of all individual case safety reports, ensuring compliance and quality.You will verify and review all forms and documents pertaining to a case for errors, missing information, legibility; and request follow up information as required. You need to verify appropriate selection of adverse event, appropriate MedDRA code assignment and accuracy of label assessments for adverse events. The appropriate selection of seriousness criteria of adverse events and accuracy of label assessment for adverse events will also need to be verified.
Good to have skills: Medical Review,Good communication skills
Roles and Responsibilities
In this role you are required to do analysis and solving of lower-complexity problems. Interaction is with peers within Accenture before updating supervisors. Likely has limited exposure with clients and/or Accenture management. Moderate level instruction on daily work tasks and detailed instructions on new assignments would be provided. Decisions impact own work and may impact the work of others . Individual contributor as a part of a team, with a focused scope of work.
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