Safety Reporting Specialist

4 days left

Company
PPD
Location
Belgrade, Serbia
Salary
Competitive
Posted
18 Sep 2019
Closes
18 Oct 2019
Ref
1162347
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Currently in PPD Serbia, we are looking for Safety Reporting Specialist.

He/She will be responsible for all submissions within regulatory timelines, to appropriate quality standards and following PPD procedures. Assists management in producing study metrics (e.g. letters submitted for each study per month) as required.

Overview of the role

  • Prepares and submits expedited safety reports to applicable parties which may include regulatory agencies, ethics committees, investigators and third parties.
  • Ensures reports are submitted within the regulatory timelines to ensure compliance.
  • Tracks all expedited safety report submissions and review compliance/produce metrics on a regular basis.
  • Assists in any specific tasks, safety issues or concerns and liaise closely with Clinical, PVG, and Regulatory Affairs teams.
  • Assists in the testing of any study tracking databases and provide input into database design as required.
  • Assists in archiving study files as required.
  • Completes all tasks in accordance with relevant SOPs/WPDs and departmental guidelines.
  • Ensures regulatory submission files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
  • Facilitates and responds to company, client and regulatory audits where required.


Qualifications:

Hiring requirements

  • Bachelor's degree in the life-science field or previous CRO experience is required.


Knowledge and skills required

  • Strong attention to detail
  • Excellent written and verbal communication skills
  • Good Microsoft Word and Excel skills; basic understanding of database functionality
  • Ability to identify and set priorities and effectively perform a variety of tasks simultaneously, including those with set deadlines
  • Knowledge of medical terminology
  • Ability to maintain a positive attitude
  • Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff members
  • Ability to work effectively within a team to attain a shared goal
  • Demonstrates initiative and completes assigned tasks with limited supervision
  • Ability to maintain focus while working within strict timelines
  • Strong critical thinking and problem solving skills


How to apply? Please submit your CV in English.

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