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Post: Medical Reviewer with Clinical Research
Job Description:
Responsible for ensuring that all Medical Review cases are processed in line with the SOPs and timelines as per the SLAs.
* Plan, organize, and manage daily work to meet service level timelines and deliverables.
* Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and UCB policies.
* Review all forms and documents pertaining to a case for errors, missing information, legibility.
* Provide guidance to the team members on the expedited cases.
* Provide medical input on difficult adverse event cases.
* Review and quality control of the serious and expedited cases as well as non serious cases.
* Responsible for submitting the final version of the Aggregate Safety Report to the client.
* Ensure US drug safety reporting regulations, ICH guidelines, and Client SOPs are applied by the team members to adverse event case reporting
* Evaluate team members’ adverse event case reports for performance improvement.
* Adjust to changing regulatory environment.
* Identify, support, and implement continuous improvement activities.
* Responsible for escalating the issues or tasks outside the normal scope of work.
* Ensure effective and efficient resource utilization.
* Define or interpret day-to-day business objectives.
Other Responsibilities –
* Responsible for the championing of process enhancements to the team, and to senior management, functional and business leaders
* Responsible for compliance and quality.
* Identifies business development opportunities and communicates them to the Client Account Lead and senior management.
* Manages Service Improvement Programmes within the Delivery operation.
* Responsible for functional Operations staff and for maintaining headcount to the agreed plan.
* Recognised as having expert knowledge and vision in Client Delivery Operation.
* Ensures team attrition is at acceptable targets
Additional Information:
Experience: 7-12 years
Location: Bangalore
Education: B.Pharm, M.Pharm, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: IT
Compensation: Rupees 2,00,000 - 5,00,000
E-mail your resume at, supriya.shekar@accenture.com
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