Drug Safety Reporting Specialist

Job Description

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.

 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.

Qualifications: Education and Experience: B

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’).

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