Greetings from Nexgen Careers
We have planned to conduct week drive Quality Control at Nexgen Careers,Coimbatore on 28-11-2016 to 03-11-2016.
Manages projects and conducts QC activities on deliverables produced by WSRO, WSS, and WRS ensuring accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations
Provides ongoing analysis of data resulting from the quality review of regulatory submission documents /ICSRs/ aggregate reports produced by WSRO, WSS, and WRS
Collaborates with MDL authors, epidemiologists, SER Management and others to develop strategies for the creation and collection of metrics data for quality analysis
Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives
Actively participates in the investment and strategy decisions related to the technology decisions related to Quality
Supports/promotes accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations
Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission requirements, electronic reporting requirements and other relevant regulatory requirements and guidances
Provides support for regulatory inspections, internal audits and/or strategic quality initiatives
Manages special projects and senior management requests associated with safety compliance
Develops and maintains an understanding of ARGUS, Pfast, and case processing activities so as ensure the accuracy of ICSRs, aggregate reports, ad hoc reports and analyses, and safety query responses
Note: In case of selected in interview, Application charges will be applicable. (Charges
Vilankurichi Road.,Coimbatore-641 035
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