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Job Details

Clinical Trial Safety Specialist

Company: Docs Global (Continental Europe)
Location: Warszawa,Poland
Reference: Ref AS-023248
Closing Date: 20 Oct 17
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for candidates with clinical or medical background who are ready to further develop their career as a Clinical Trial Safety Specialist.


Roles & Responsibilities of the position

The Clinical Trial Safety Specialist (CTSS) will be responsible for reviewing important and pre-specified safety data in late phase clinical trials.

•Ensure consistent processes and efficient review of trial safety data
•Responsible for handling of safety data – review for medical completeness, medical accuracy, and coding consistency
•Prepare and review queries to obtain critical or missing serious adverse events (SAE) information for appropriate medical assessment and case closure
•Review of patient-level AE/SAE study safety data on an ongoing basis to ensure medical accuracy and completeness and generate applicable queries as needed
•Contribute to study start-up activities such as the generation of the Safety Management Plan, Safety Handling Plan, and input to the relevant eCRF modules and safety sections of the Clinical Study Protocol
•Provide input into the process of setting automated patient narratives, if applicable
•Provide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process
•Work with the study physician and/or clinical scientist to support high-level data review and medical evaluation

Job Requirements

•Advanced degree in a medical profession such as pharmacist, nurse, nurse practitioner, dentist, with pharmacovigilance background, or equivalent work experience in directly related fields
•Knowledge of SAE reporting requirements
•Clinical/medical background in nursing providing a stable knowledge base for reviewing SAEs and other safety event
•Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information
•Computer proficiency
•Excellent knowledge of spoken and written English

Remuneration & other details

We offer:
·Competitive salary
·Work in the global organization in Poland
·development opportunities with rapid growing organization

To Apply:
Please contact Dagmara Drozdowska, Recruitment Consultant at DOCS on +48 668 87 02 61 or email your up-to-date CV to:

About DOCS:
DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.

Key words:
Safety, Pharmacovigilance, Study Conduct, DM, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Permanent, Warsaw, Poland

Apply for this job: Clinical Trial Safety Specialist

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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