Safety Administrator

hace 3 semanas

Xico, México Thermo Fisher Scientific A tiempo completo
Key Responsibilities

As a Safety Administrator at Thermo Fisher Scientific, you will be responsible for managing the safety profile of new drugs in clinical trials, overseeing case-processing activities through all phases of development, and performing regulatory reporting and medical monitoring.

Key responsibilities include:

  • Providing contracted project coordination and safety support on global and domestic programs
  • Liaising and establishing effective relationships with internal functional team members to implement projects
  • Preparing contractual documents, coordinating and facilitating meetings, and accurately managing all incoming safety documentation
  • Representing the PPD DSMB/EAC Coordination Team at global and domestic committee meetings
  • Compiling adjudication dossiers and creating/submitting follow-up to investigative sites
  • Managing project specific training and the set-up, maintenance, and archival of program files
  • Performing data entry into internal/external databases, tracking systems, and PPD's budget management system
  • Overseeing expenses and managing translations

Requirements

To be successful in this role, you will need:

  • Previous experience in a similar role, providing the knowledge, skills, and abilities to perform the job
  • Strong problem-solving skills, ability to work independently, and build strong relationships
  • Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access)
  • Ability to identify and set priorities, effectively perform a variety of tasks simultaneously, and maintain a positive and professional demeanor in challenging circumstances

About Thermo Fisher Scientific

Thermo Fisher Scientific is a leading provider of scientific instrumentation, reagents, and services. We enable our customers to make the world healthier, cleaner, and safer. Our mission is to enable our customers to make a positive impact on a global scale.

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