Drug Safety Manager
About the role
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- Ensure that projects within Medical and Safety run efficiently, accurately and in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors
- Ensure the daily project operations of assigned safety projects
- Provide project management on Drug Safety projects
- Oversee Drug Safety and Administrative staff, as assigned
- 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 scope activities
- *Assist upper management with resourcing and business development activities
- *Attend bid defence meetings, as requested
- *Manage small to mid-size 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 MSS projects in accordance with established timelines , budget, quality standards and/or contractual requirements
- *Develop supporting staff skills, encourage growth and provide regular performance feedback
- *Provide project and/or line management of assigned Drug Safety and Administrative staff
- *Serve as a mentor and role model for Drug Safety staff.
- A minimum of 4 years of relevant clinical research I pharmaceutical industry experience, preferably with at least 2 years experience in pharmacovigilance I drug safety .
- Advanced proven relevant clinical research I pharmaceutical industry experience, preferably in pharmacovigilance I drug safety.
- Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors , or Sponsors
- Demonstration of professional demeanour, judgment and discernment in interactions with clients, colleagues, and other staff
- Thorough knowledge of global safety processes and regulations
- Good knowledge of medical terminology and coding systems
- Very good computer skills
- Excellent organizational skills
- Excellent communication skills
- Very good presentation skills
- Very good ability to mentor staff
- Ability to work independently or lead study teams
- Ability to self-start and show initiative
- Detail oriented
- Fluent in written and verbal English
- Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Drivers license.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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