Safety Writer

Cambridge, United Kingdom
17 Jul 2019
16 Aug 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)
This is a great opportunity for experienced Safety Writers working within the pharmaceutical, biotech and Contract Research Organisation (CRO) sector, to work for a global leading CRO.

As PPD is a trusted partner of some of the most innovative pharmaceutical and biotech companies, our Safety Writers have the opportunity to work on a variety of projects across a wide range of therapeutic areas. Our vision is to be a global leader in our industry for delivery of aggregate safety reports and risk management documents, based on consistent quality and execution, exceptional customer-aligned service and constant innovation.

You should have significant safety 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 should be able to understand, interpret, analyse and present complex medical and scientific data, and have a high attention to detail. As you may be working on multiple reports at the same time, you should have strong organisational skills, including the ability to prioritise work to ensure that all timelines are adhered to. You must be comfortable with having direct interaction with external clients, as you will be responsible for running meetings and presenting to current/potential clients as well as managing review and comment resolution stages of document preparation.

In return we offer you a positive and supportive working environment within one of the most engaged teams in the industry, who are recognised as the cornerstone of our success. We provide you with the opportunity to acquire valuable professional skills and experience.



* Bachelor's or higher medical science degree.

*Must have a minimum of two years' experience in authoring two or more of the following report/document types for medicinal products :

• DSUR (Development Safety Update Report)

• PBRER / PSUR (Periodic Benefit Risk Evaluation Report / Periodic Safety Update Report)

• PA(D)ER (Periodic Adverse [Drug] Experience Report)

• RMP (Risk Management Plan)

* Good understanding and knowledge of aggregate safety report writing guidelines, and clinical trial and post-marketing pharmacovigilance legislation in relation to medicinal products.

* Experience of authoring medical device aggregate safety reports or clinical evaluation reports is preferable, although not essential.

* Task based project management experience and experience with interacting directly with internal and/or external stakeholders.

* Excellent English - both written and verbal.

* Advanced knowledge of Microsoft Office software.


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