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Thermo Fisher Scientific is seeking a Safety Writer III to oversee safety writing services for clinical trials and marketed products. The role involves project management, data review, and the authoring of safety-related documents in a regulated environment, while collaborating with various teams and clients.
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Job Summary
This role involves planning, coordinating, and delivering safety writing services for clinical trials and marketed products within a highly regulated pharmacovigilance environment.
The successful candidate will manage a wide range of deliverables from low to high complexity, including Periodic Safety Update Reports and Risk Management Plans.
Join a global team that values passion, innovation, and scientific excellence while ensuring operational excellence that makes a real difference in patient safety.
Matching Summary
Match Score: 75
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Thermo Fisher Scientific is seeking a Safety Writer III to oversee safety writing services for clinical trials and marketed products. The role involves project management, data review, and the authoring of safety-related documents in a regulated environment, while collaborating with various teams and clients.
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Skills & Requirements
Must-have
6 years experience in safety writing
Authoring DSURs, PBRERs, PA(D)ERs, RMPs
Knowledge of ICH and US aggregate formats
Project management of clinical trial deliverables
Quality review and senior review tasks
Nice-to-have
Mentoring less experienced staff
Leading kick-off meetings and client interactions
Advanced critical thinking and problem solving
Budget activities and forecasting skills
Subject matter expert in designated area
Key Requirements
Bachelor's or higher scientific degree
Minimum 6 years experience in authoring and QC review
Experience with innovative medicinal product reports