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Drug Safety Manager

042547_2

About the role

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Overview:
  • 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

Responsibilities:
  • 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
Supervision:
  • *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.
Experience/Skills.Requirements:
  • 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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