Safety Reporting Specialist

Position Overview

• Location Type: Office
• Job Type: Full-time
• Work Schedule: Standard (Mon-Fri)
• Salary: Not specified

As a Safety Reporting Specialist, you will be responsible for the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. You will assist management in producing project metrics as required and may take a lead role on projects and programs relating to safety reporting.

A Day in the Life

• Receive, prepare, and submit safety reports to applicable parties.
• Raise any encountered issues to the Lead and/or line manager.
• Ensure reports are submitted in compliance with regulatory timelines and country legislation.
• Assist in producing metrics and alert the manager to any quality or timeline issues.
• Participate on project teams and may lead projects of small to moderate scope.
• Provide training and support to other team members.
• Perform administrative tasks such as filing and the maintenance of safety reporting systems and information.
• Liaise with various departments around safety reporting tasks and the setting up of client accounts.
• Participate in audits where required and perform testing activities as needed.
• Share ideas and suggestions with team members, ensuring effective communication and participating in process improvement initiatives.

Requirements

• Education: Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Knowledge, Skills, and Abilities:
  • Strong knowledge of medical terminology.
  • Good written and verbal communication skills.
  • Good Microsoft Word and Excel skills.
  • Solid understanding of safety database functionality.
  • Proven knowledge of procedural documents.
  • Working knowledge of global safety reporting requirements (including FDA regulations and guidelines).
  • Ability to balance multiple tasks while still delivering high-quality results.
  • Strong attention to detail and accuracy with an orientation toward careful and meticulous work.
  • Maturity to handle sensitive information and data optimally.
  • Ability to interact effectively with all levels of the organization.
  • Strong critical thinking and problem-solving skills.

Company Information

• Environmental Conditions: Office