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Job Details

Safety Submission Specialist - Turkey

Company: Syneos Health
Location:
Reference: PL - 18004525
Closing Date: 19 Aug 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Here at Syneos Health we are looking for Safety Submission Specialist to be office-based in Istanbul, Turkey

Requirements:

MAJOR RESPONSIBILITIES

  • Process adverse event reports received from sites/reporters.
  • Perform QC review of completed individual and periodic safety reports.
  • Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information.
  • Generate adverse event queries, liaise with the medical reviewers/client to agree upon the queries, and send request for additional information to the sites/reporter.
  • Engage with the Site Monitors to ensure follow up information is obtained from site effectively.
  • Foster constructive and professional working relationships with all project team members, internal and external.
  • File documents according to project specific requirements (electronically or in hard copy as applicable).
  • Ensure case files are compliant with SOPs.
  • Distribute safety data reports to other Safety Associate peer and Medical Monitor for review.
  • Distribute safety data reports to clients and other relevant parties.
  • Ensure compliance with company policies, procedures, and standards.
  • Participate in audits as required/appropriate.
  • Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects.
  • Mentor or train less experienced Safety Associates on processes regarding case management.
  • Perform literature review as appropriate for Post-Marketing cases.
  • Maintain knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
  • Any other duties as assigned by manger.

Qualifications/Requirements

  • Bachelors Degree, preferably in a life science, nursing, pharmacy and two years of relevant with one year of safety/PV experience. Relevant experience could include data management, CRA, clinical practice, regulatory authority, or study coordinator experience
  • In lieu of degree or Healthcare Professional license/certification, a total of three years safety/PV experience may be considered.
  • Familiarity with safety database systems: ARISg or Argus preferred
  • Ability to successfully prioritize and work on multiple tasks
  • Excellent team player and attention to detail
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
  • Excellent knowledge of ICH guidelines and regulations relating to safety reporting.
  • Computer proficient including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS Powerpoint), email software (Outlook), diagramming/workflow software (MS Visio), and spreadsheet software (MS Excel)
  • Ability to travel as necessary (less than 5%).

Apply for this job: Safety Submission Specialist - Turkey

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68 02-014 Warsaw (Warszawa)

Poland
Website:  Visit Our Web Site

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