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Job Details

Aggregate Safety Report Writer, Sr Safety Specialist-142594

Company: PPD
Location: Europe, Middle East & Africa-Bulgaria-Sofia-Sofia
Reference: 142594
Closing Date: 18 Dec 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...

Requirements:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.

PPD has an exciting opportunity for an Aggregate Safety Report Writer to join our pharmacovigilance team.

This is a great opportunity for Safety Specialist, Aggregate Safety Report Writers at any level currently working within the life science sector for pharmaceutical companies, Biotech companies or CRO’s, having scientific or medical writing experience and who would enjoy the opportunity to work for a global leading CRO.

As the trusted partner of some of the most innovative big pharma and biotech companies, our Aggregate Safety Report Writers have the opportunity to work on challenging projects across a wide range of therapeutic areas. Our vision is to be the global leader in our industry, based on consistent quality and execution, exceptional customer-aligned service and constant innovation.
You should 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. As you may be working on multiple reports at the same time, you should have strong organizational skills, including the ability to prioritize work to ensure that strict timelines are adhered to. You must be comfortable with having direct interaction with clients, as you will be responsible for running meetings and managing review and comment adjudication 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 recognised as the cornerstone of our success. We will provide you with the opportunity to acquire valuable personal and professional skills.

Qualifications

Candidate Requirements:

•    Bachelor’s or higher scientific degree.
•    Good understanding and knowledge of aggregate safety report writing guidelines.
•    Excellent English – both written and verbal.
•    Advanced knowledge of Microsoft Office package.
•    Task based project management experience and experience with interacting directly with clients.

•    Knowledge of both clinical trial and post-marketing pharmacovigilance is preferable, although  not essential.
•    Must have a minimum of one year’s experience in authoring two or more of the following report/document types:
-    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:   As a compensation, you will be provided with a competitive remuneration, corporate training and the opportunity to become a part of a fast growing, multinational company.   At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. Employees who embrace excellence have a chance to earn rewards. 

How to apply:

Please submit your CV in English.

Registration on our website will also give you the opportunity to be considered for other positions if this one is not the most appropriate for your qualifications and experience.

Only short-listed candidates will be contacted.

PPD is an equal opportunities employer

*LI-GG1



Apply for this job: Aggregate Safety Report Writer, Sr Safety Specialist-142594

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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