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Drug Safety Manager

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DRUG SAFETY MANAGER, Japan
 
PURPOSE OF THE JOB:
  1. Ensure that projects within Medical Affairs and Drug Safety run efficiently, accurately and in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors
  2. Provide project management on Drug Safety projects
  3. Oversee Drug Safety and Administrative staff as assigned
 
JOB FUNCTIONS/RESPONSIBILITIES:
 
  1. Provide line management of Drug Safety, Systems and Administrative staff assigned
  2. Ensure all project safety activities are completed in accordance with SOPs, SSPs, and other applicable regulations
  3. Keep management appraised of any potential/actual study or staffing issues and assist with developing solutions
  4. Coordinate and implement department training and identify training needs; provide Medical Affairs and Drug Safety training to other departments as requested
  5. Maintain quality review metrics and attend other project quality meetings as required
  6. Supervise maintenance of project drug safety files as regionally applicable
  7. Assist with maintenance of project budgets and oversight by identifying out of scope activities
  8. Serve as a mentor and role model for Drug Safety staff
  9. Assist upper management with resourcing and business development activities 
  10. Manage drug safety projects including Sponsor liaison, and management of timelines and budgets as appropriate
  11. Coordinate DSMB activities
  12. Ensure audit readiness and Medical Affairs representation at audits
  13. Develop safety plans and workflows for clients
  14. Other activities as identified and requested by management
 
QUALIFICATIONS/EXPERIENCE REQUIRED:
 
  1. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. (US)
  2. Medical /science background (nursing, pharmacy or medicine preferred) with relevant clinical experience, 5 years drug safety or equivalent experience; prior supervisory or mentoring experience
  3. Demonstration of professional demeanor, judgment and discernment in interactions with Clients, colleagues, and other ICON staff.
  4. Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors
  5. Excellent computer skills 
  6. Excellent organizational and time management skills
  7. Excellent verbal and written communication skills
  8. Excellent presentation skills
  9. Fluent in written and verbal English / NATIVE JAPANESE

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