Data Analyst
Cognizant Technology Solutions
Keywords
Data Analysis
Case Analysis
Databases
Labeling
Quality Management
Team Management
Skills
ICSR processing, quality metrics, Medical device case processing, Database, MS Excel, powerpoint, MS word, Event Labeling, Team management, Late case analysis
Project history
10/2016
-
05/2021
Job Description
* Responsible to perform processing of ICSRs, quality review of serious and non serious ICSRs.
* Segregation and analysis of data daily by Medra coded preferred terms, prioritization and
monitoring of cases through workflow to meet client requirements.
* Act as a back up team lead in absence of team lead and monitor the workflow.
* Handling weekly client meeting to discuss the feedback from the client QC.
* Conducting trainings in team regarding any new updates or communication related to project.
* Effectively mentor and train new team members in the project.
* proactively identifies, escalates, resolves/mitigates, risks and/or issues
* Reviews adverse event documents prepared by the Patient Safety personnel for accuracy,
completeness, and compliance
* Conducts training in both classroom and individualized settings
* Responsible to perform processing of ICSRs, quality review of serious and non serious ICSRs.
* Segregation and analysis of data daily by Medra coded preferred terms, prioritization and
monitoring of cases through workflow to meet client requirements.
* Act as a back up team lead in absence of team lead and monitor the workflow.
* Handling weekly client meeting to discuss the feedback from the client QC.
* Conducting trainings in team regarding any new updates or communication related to project.
* Effectively mentor and train new team members in the project.
* proactively identifies, escalates, resolves/mitigates, risks and/or issues
* Reviews adverse event documents prepared by the Patient Safety personnel for accuracy,
completeness, and compliance
* Conducts training in both classroom and individualized settings
11/2012
-
09/2016
Operations specialist
Quintiles Research India Pvt Ltd
Job Description
* Initial receipt, Database searches as necessary. Registry and Triage of incoming cases to
determine seriousness for prioritization of daily workflow.
* Performed complete Case receipt, processing and quality review of all spontaneous non-serious and
reports from therapeutic areas and clinical trials.
* Highly productive and diverse case processor. Recognized as a quick learner in case processing,
quality review and organization.
* Completed all assigned tasks and reports within company stipulated timelines and quality.
* Organization liaison for issues and coordinated with the client and company including initiating
and driving client calls, preparing and circulating project status reports and minutes of meetings
and root cause analysis of the quality report.
* Other case processing related activities (e.g. review of consistency checks, reconciliation, TFUQ
review etc.)
* Labeling segregation, review of CCDS and appropriate updates
* Mentoring the new associates and provide quality feedback to team resources.
* Being a literature SME worked as mentor for team.
* Single case unblinding.
* Track and maintain quality metrics.
* Participation in inspection and audits
* Initial receipt, Database searches as necessary. Registry and Triage of incoming cases to
determine seriousness for prioritization of daily workflow.
* Performed complete Case receipt, processing and quality review of all spontaneous non-serious and
reports from therapeutic areas and clinical trials.
* Highly productive and diverse case processor. Recognized as a quick learner in case processing,
quality review and organization.
* Completed all assigned tasks and reports within company stipulated timelines and quality.
* Organization liaison for issues and coordinated with the client and company including initiating
and driving client calls, preparing and circulating project status reports and minutes of meetings
and root cause analysis of the quality report.
* Other case processing related activities (e.g. review of consistency checks, reconciliation, TFUQ
review etc.)
* Labeling segregation, review of CCDS and appropriate updates
* Mentoring the new associates and provide quality feedback to team resources.
* Being a literature SME worked as mentor for team.
* Single case unblinding.
* Track and maintain quality metrics.
* Participation in inspection and audits
Local Availability
Only available in these countries:
India
Other
Available for freelance PV case processing, quality review, CAPA and deviation analysis
