Senior Safety Reporting Coordinator

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom Thermo Fisher Scientific Full time
{"title": "Safety Reporting Coordinator", "content": "Overview

At Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. As a Safety Reporting Coordinator, you will play a critical role in managing the safety profile of new drugs in clinical trials, overseeing case-processing activities, and performing regulatory reporting and medical monitoring.

Responsibilities
  • Provide administrative safety support to the safety reporting team and Pharmacovigilance department.
  • Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department's projects.
  • Assist with allocation of work tasks to safety reporting team members as well as oversight for completion of work tasks by others.
  • Provide assistance with planning and coordination of large and complex projects relating to safety reporting. With input and supervision from superiors, leads complex projects including project oversight and collation, maintenance, and delivery of metrics.
  • Recommends and performs updates to procedures, regulatory intelligence activities, and other initiatives related to safety reporting.
  • Provides training, guidance, and support to safety reporting team members.
Requirements
  • Bachelor's degree in life science/healthcare-related courses (nursing, pharmacy, biology, med tech, etc).
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
  • Ability to work effectively in a team environment, and as a lead, to attain a shared goal and support line manager on tasks.
  • Ability to work effectively as an individual and independently to attain the wider goals of the team.
  • Excellent proficiency in Microsoft Office Programs (Word, Excel, PowerPoint).
  • Strong knowledge of Pharmacovigilance and industry terminology.
  • Excellent written and verbal communication skills, including telephone conversations as well as face-to-face interaction internally within the department.
  • Ability to identify and prioritize tasks, for self and others, simultaneously along with handling numerous deadlines and stay focused during these times.
  • Ability to work under pressure without jeopardizing work standards.
  • Ability to interact effectively with all levels of the organization.
  • Possess the maturity to handle sensitive information and data effectively and to act accordingly as required.
  • Excellent knowledge of procedural documents with the ability to identify gaps in processes and offer constructive suggestions for solutions performing review and updates as required.
  • Excellent critical thinking and problem-solving skills and attention to detail.
  • Excellent organization and time management skills with proven ability to handle multiple tasks at once and deal effectively with pressure while maintaining excellent attention to detail and accuracy with orientation towards careful and meticulous work.
  • Ability to apply knowledge, skills, and expertise to assist other colleagues in safety reporting activities.
  • Demonstrates initiative and utilizes persuasion and negotiation skills to influence colleagues and team peers.
"}

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