Safety Writer Iv

PPD (Thermo Fisher) UK

Remote
Safety writing in pharmacovigilance
Project management skills
Data review and quality control
As a Safety Writer IV, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and/or marketed product projects, including where the company serves as a pharmacovigilance functional service provider to the client in question

Job Summary

  • As a Safety Writer IV, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and/or marketed product projects, including where the company serves as a pharmacovigilance functional service provider to the client in question.
  • You will effectively collaborate with various parties including PV project team members, wider project teams, client contacts, and third-party vendors while performing day-to-day safety writing activities within a highly regulated environment driven by strict timelines.
  • When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence, working in an environment where collaboration and development are part of the everyday experience.

Matching Summary

As a Safety Writer IV, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and/or marketed product projects, including where the company serves as a pharmacovigilance functional service provider to the client in question.

Skills & Requirements

Must-have

  • Safety writing in pharmacovigilance
  • Project management skills
  • Data review and quality control
  • Knowledge of ICH and US safety reporting
  • Use of multiple client systems
  • Collaboration with cross-functional teams

Nice-to-have

  • Mentoring and training staff
  • Leading departmental initiatives
  • Advanced Microsoft Office skills
  • Strong problem solving abilities
  • Effective communication skills
  • Ability to work under pressure

Key Requirements

  • Bachelor's or higher scientific degree
  • Minimum eight years experience in safety writing
  • Experience authoring DSURs, PBRERs/PSURs, PA(D)ERs, RMPs
  • Knowledge of global pharmacovigilance regulations

Work Rights

Not specified

Tailored Resume

Cover Letter