Safety Writer III

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Hiring Remotely in Agios Thomas
Remote
Internship
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role

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. 

The Company
HQ: Waltham, MA
100,000 Employees
Hybrid Workplace

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

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