Drug Safety Manager
About the role
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* Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
* As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
* Travel (approximately 15%) domestic and/or international
* Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
* Serve as the main point of contact for the customer for the life-cycle of assigned stand alone projects, and the main pharmacovigilance point of contact for assigned full-service projects
* Ensure the assigned project contracted tasks are completed according to project specific procedures and meet key metrics
* Oversee implementation of projects including client communications, project specific plans, system set-up, and establishment of appropriate and agreed-upon metrics
* Completion of project status reports/review meetings including burn hours, profit margins, quality review findings and other metrics
* Lead identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required
* Coordinate and present at meetings (project and department) as required
* Support QPPV as required
* Develop and maintain excellent client relationships
* Assisting the Director/Senior Director to develop and grow capabilities, productivity, and quality levels.
* Actively participate in quality and training initiatives
* Participate in process improvement by actively identifying process improvements, developing better procedures, and working to additionally implement those change / process improvements
* Interview, evaluate and recommend new PVSS hires
* Train/mentor Drug Safety Coordinator and other Drug Safety Manager staff*
* Develop staff for succession planning, ie, develop next generation of management/leaders
* Coordination and participation in interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities)
* Participate in Business Development activities as requested
* Perform other activities as identified and requested by management
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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