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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.