Job Description
Responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department's projects. Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects.
Essential Functions
Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are
submitted in compliance with regulatory timelines and country legislation.
Assists in producing metrics and alerts manager to any quality or timeline issues.
Participates on project teams and may lead projects of small to moderate scope. Provides training and support to other team members.
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Performs administrative tasks such as filing and the maintenance of safety
reporting systems and information.
Liaises with various departments around safety reporting tasks and the setting
up of client accounts.
Participates in audits where required and performs testing activities as needed.
Shares ideas and suggestions with team members ensuring effective
communication and participates in process improvement initiatives.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years').
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Strong knowledge of medical terminology
Good written and verbal communication skills
Good Microsoft Word and Excel skills and solid understanding of safety database functionality
Solid knowledge of procedural documents and working knowledge of global safety reporting
requirements (including FDA regulations and guidelines)
Ability to juggle multiple tasks while still delivering high quality results
Strong attention to detail and accuracy with orientation toward careful and meticulous work
Possess the maturity to handle sensitive information and data effectively
Ability to interact effectively with all levels of the organization
Strong critical thinking and problem solving skills