Safety Reporting Specialist

hace 1 mes

Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, we're committed to enabling our customers to make the world a healthier, cleaner, and safer place. As a key member of our team, you'll play a critical role in bringing our mission to life. Our team members handle the safety profile of new drugs in clinical trials, lead all aspects of case-processing activities through all phases of development, and perform regulatory reporting and medical monitoring tasks.

A Day in the Life

  • Receives, prepares, and submits safety reports to applicable parties, ensuring compliance with regulatory timelines and country legislation.
  • Assists in producing metrics and alerts managers 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 maintaining safety reporting systems and information.
  • Liaises with various departments around safety reporting tasks and the setting up of client accounts.
  • Participates in audits and performs testing activities as needed.
  • Shares ideas and suggestions with team members, ensuring effective communication and participating in process improvement initiatives.

Keys to Success

Education

Bachelor's degree

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Experience

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, 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 successfully with all levels of the organization.
  • Strong critical thinking and problem-solving skills.

Our mission is to enable our customers to make the world a healthier, cleaner, and safer place. We're committed to accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

Apply today

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.

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