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.
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