Safety Writer III

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

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 III 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 preparation

> 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

> 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 RMP and aggregate safety report writing guidelines, clinical trial, and post-marketing pharmacovigilance

In addition, you must have a minimum of two years' experience in authoring the following report/document types for medicinal products:

EU RMPs and Core RMPs for innovative medicinal products (experience in authoring the full document is a requirement).

DSURs (Development Safety Update Reports)

PBRERs / PSURs (Periodic Benefit Risk Evaluation Reports / Periodic Safety Update Reports)

PA(D)ERs (Periodic Adverse [Drug] Experience Reports)

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.