Safety Writer III

October 3

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• This is a great opportunity for experienced Safety Writers currently working within the life science sector for pharmaceutical companies, biotech companies or Clinical Research Organizations (CROs), to work for a global leading CRO. • Our Safety Writers have the opportunity to work on challenging projects across a wide range of therapeutic areas. • You should have significant scientific or medical writing experience, thrive in project teams and be focused on delivering exemplary levels of customer service. • Capable of concise and clear written and verbal communication; you will be able to understand, interpret, analyze and present complex data and have a high attention to detail. • You must be comfortable with having direct interaction with clients, as you will be responsible for running meetings and managing review and comment resolution stages of document preparation. • In return we will offer you a positive and supportive working environment within one of the most engaged teams in the industry; who are recognized as the cornerstone of our success. • We will provide you with the opportunity to acquire valuable personal and professional skills.

Requirements

• Bachelor’s or higher scientific degree. • Excellent English – both written and verbal. • Advanced knowledge of Microsoft Office package. • Task based project management experience and experience with interacting directly with clients. • Good understanding and knowledge of aggregate safety report writing guidelines, and clinical trial and post-marketing pharmacovigilance. • Experience of authoring device aggregate safety reports or clinical evaluation reports is preferable, although not essential. • Must have a minimum of two years’ experience in authoring two or more of the following report/document types for medicinal products : • DSURs (Development Safety Update Reports) • PBRERs / PSURs (Periodic Benefit Risk Evaluation Reports / Periodic Safety Update Reports) • PA(D)ERs (Periodic Adverse [Drug] Experience Reports) • RMPs (Risk Management Plans)