PRAHS

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2017-43900

2017-43900

Title 
Safety Scientist
Job Locations 
-
Germany-Mannheim
France
United Kingdom
Spain
EU-Remote
Posted Date 
12/4/2017

More information about this job

Overview

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 70+ such drugs.

 

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

 

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 13,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community. 

 

For more information please see our website: www.prahs.com

 

 

Responsibilities

We are currently looking for an experienced Safety Scientist to join our team in Europe.

 

The Safety Scientist provides internal and external project teams with expert knowledge on safety surveillance for medicinal products and devices, risk management, and medical coding questions. He/she supports or initiates process and/or system development or improvement activities. In addition he/she develops and provides training and mentorship to less experienced team members.

  • Provides project team with expert knowledge on safety surveillance for medicinal products and devices, risk management and medical coding questions.
  • Assists project team in client meetings, when pharmacovigilance, risk management and medical coding questions which require expert knowledge beyond the expertise of Drug Safety Associates and/or Safety Data Coordinators are discussed.
  • Coordinates and facilitates specialized Safety and Risk Management services, such as, writing/generating aggregate safety reports, dRMP/RMP, and Literature Search and Review Algorithms, and their associated plans.
  • Writes Aggregate Safety Reports.
  • Performs quality control activities.
  • Participates in PRA initiatives for the implementation and integration of new or enhanced:
    • Safety & Risk Management processes and best practices
    • Safety & Risk Management systems, databases and tools
  • Contributes to system development life cycle activities.                 
  • Provides technical guidance and mentorship for Drug Safety Associates or Safety Data Coordinators.
  • Represents PRA in conferences and user group meetings related to Safety & Risk Management Services.
  • Maintains an understanding of clinical research development, safety and risk management obligations during the entire product life cycle, safety processes and regulatory requirements, medical terminology and standardized coding dictionaries.
  • Develops and delivers training courses on Safety & Risk Management related topics to PRA employees within and outside Safety & Risk Management, as well as to external parties (investigators, clients). 

Qualifications

In order to be successful in this position you should have

  • Substantial clinical research or post-marketing safety surveillance experience required with a minimum of 3 years experience in pharmacovigilance or medical coding or in a similar field.
  • Experience in leading professional staff in a safety surveillance, risk management and medical coding environment required with proven ability to oversee, mentor and effectively manage co-workers.
  • Read, write, and speak fluent English; fluent in host country language required.
  • Undergraduate degree in clinical, science, or health-related field from an accredited institution, or equivalent work experience required.
  • Skills with industry standard safety or clinical data bases.

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

 

Location: This role can be home- or office-based in Europe.

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