Marcia CULBREATH

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  <ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health<ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health