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13.02.2019, Ref.#: 150200
★★★ Aggregate Safety Report Writer, ПИ ПИ ДИ БЪЛГАРИЯ ЕООД
Месторабота София; Постоянна работа; Пълно работно време; Езици: Английски
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Aggregate Safety Report Writer
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.

This is a great opportunity for experienced Safety Writers working within the pharmaceutical, biotech and Contract Research Organization (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, analyze 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 organizational skills, including the ability to prioritize 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 recognized as the cornerstone of our success. We provide you with the opportunity to acquire valuable professional skills and experience.

Education and Experience:
• Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experience OR Life Science degree and 1 year of pharmacovigilance experience
• Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job

Knowledge, Skills and Abilities:
• Our ideal candidate will 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.

How to apply:
Please submit your CV in English.

Only short-listed candidates will be contacted.

PPD is an equal opportunities employer
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