Safety Writer II

Work Schedule

Environmental Conditions

Job Description

About Thermo Fisher Scientific Inc.

Thermo Fisher Scientific Inc. is a global leader in the life science sector, providing world-class solutions to pharmaceutical companies, biotech companies, and Clinical Research Organizations (CROs). As the trusted partner of some of the most innovative big pharma and biotech companies, we offer exceptional opportunities for experienced Safety Writers to work on exciting projects across a wide range of therapeutic areas.

Job Description
As a Safety Writer at Thermo Fisher Scientific, you will play a crucial role in ensuring the flawless delivery of scientific and medical writing services. You will thrive in project teams, delivering outstanding levels of customer service and collaborating with clients to successfully conduct projects. Your responsibilities will include:

• Understanding, interpreting, analyzing, and presenting complex data
• Writing concise and clear reports and documents
• Managing multiple reports simultaneously and prioritizing work to meet strict timelines
• Facilitating meetings and managing the review and comment resolution stages of document preparatio
• Interacting directly with clients and providing exceptional customer service

Job Requirements

To qualify for this position, you must possess the following qualifications:

• Bachelor's or higher scientific degree with 2 or more years of experience that aligns with the expectations of the role
• Excellent written and verbal English interpersonal skills
• Advanced knowledge of Microsoft Office package
• Task-based project management experience and experience with client interaction
• Good understanding and knowledge of aggregate safety report writing guidelines, clinical trial, and post-marketing pharmacovigilance
• Experience authoring device aggregate safety reports or clinical evaluation reports is preferable

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

In addition, you 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)

Our Offer

At Thermo Fisher Scientific, we offer a positive and supportive working environment within one of the most engaged teams in the industry. We recognize our employees as the cornerstone of our success and provide opportunities for personal and professional growth. In addition, we offer a driven remuneration package and corporate training.

To apply for this position, please submit your CV in English through our website.

Please note that only short-listed candidates will be contacted.

Thermo Fisher Scientific is an equal opportunities employer.