Drug Safety Reporting Specialist II

Job Description

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.  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.