Safety Writer Ii

PPD (Thermo Fisher) UK

Remote, ,
Safety writing for clinical trials
Pharmacovigilance regulatory compliance
Project management in safety writing
As a Safety Writer II, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and marketed product projects within a highly regulated pharmacovigilance environment

Job Summary

  • As a Safety Writer II, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and marketed product projects within a highly regulated pharmacovigilance environment.
  • You will collaborate effectively with project team members, clients, and third-party vendors while managing deliverables ranging from low to high complexity and serving as the primary point of contact for assigned projects.
  • Joining Thermo Fisher Scientific means becoming part of a global team that values passion, innovation, and scientific excellence, offering an environment where collaboration and development are integral.

Matching Summary

As a Safety Writer II, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and marketed product projects within a highly regulated pharmacovigilance environment.

Skills & Requirements

Must-have

  • Safety writing for clinical trials
  • Pharmacovigilance regulatory compliance
  • Project management in safety writing
  • Medical-scientific writing skills
  • Use of Microsoft Office and multiple systems
  • Data review and quality control

Nice-to-have

  • Mentoring less experienced staff
  • Strong critical thinking and problem solving
  • Ability to work effectively within a team
  • Positive and professional demeanor
  • Experience with budget activities and forecasting

Key Requirements

  • Bachelor's degree or higher scientific degree
  • Minimum five years' experience in safety writing
  • Experience authoring DSURs, PSURs/PBRERs, PA(D)ERs, and RMPs
  • Comprehensive knowledge of ICH and US aggregate safety reporting
  • Strong English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter