Drug Safety Manager
About the role
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The purpose of this role is ensuring expedited and periodic safety reporting compliance. The position covers a broad spectrum of safety reporting activities globally and leadership to the safety reporting team in Europe and South America.
- Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
- 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 (up to approximately 15%) domestic and/or international as applicable
- Ensure all project safety activities are completed in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes
- Keep management appraised of any potential/actual study or staffing issues and develop solutions for same
- Develop and implement department training
- Assist in training of other departments, as requested
- Maintain quality review metrics and attend project quality meetings, as required
- Assist with maintenance of project budgets and oversight by identifying out of scopeactivities
- Assist upper management with resourcing and business development activities
- meetings, as requested
- Manage small to midsize drug safety projects, including Sponsor liaison, and management of timelines and budgets, as appropriate
- Ensure audit readiness and/or MSS representation at audits
- Develop safety plans, study specific procedures, and workflows for clients, as requested
- Actively identify options for process improvement
- Supervise maintenance of project drug safety files as regionally applicable
- Coordinate any committee activities as applicable under supervision
- Perform other activities as identified and requested by management
- Manage REG GRA projects in accordance with established timelines , budget, quality standards and/or contractual requirement
- Develop supporting staff skills, encourage growth and provide regular performance feedback
- Provide project and/or line management of assigned REG staff
- Serve as a mentor and role model for REG staff.
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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