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Job Details

Safety Specialist I - Submissions

Company: DOCS Global
Location: Cambridge,United Kingdom
Reference: Ref AS-024871
Closing Date: 22 Apr 18
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

This is an excellent opportunity to join one of the fastest growing drug safety organisations in the UK. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.


Roles & Responsibilities of the position

Triage is the assessment and evaluation of safety information so that cases can be prioritized for data entry based on reporting requirements. A specialist will perform case triage, reviewing all the source documents for the version received to ensure appropriate assessment of the case and confirming the following:
• Case validity
• Case receipt date of report
• Our clients product encoded properly and is the primary product
• Seriousness for each event
• Expectedness/Listedness for each event using appropriate reference safety information
• Causality for each event

Triage activities include but not limited to the following responsibilities:
•The Service Provider will sort by earliest awareness date the cases in triage within the Global Safety Database Worklist by routinely checking for potential priority reports including fatal and life-threatening
•The Service Provider will verify, enter and code events in accordance with our clients procedure documents and conventions. The Service Provider will assess and enter seriousness criteria, expectedness and causality and ensure accurate capture of each event term or reaction term at the event level as well as at the case level based on regulatory requirements and our clients specific product rules (e.g., Always Serious List, product specific events of interest).
•The Service Provider will ensure our clients products/compounds are selected from the company library in the Global Safety Database
•The Service Provider will document the assessment and prioritize the case entry based on the case receipt date and triage assignment
•The Service Provider will assign/reassign same source/multiple cases to one specific Case Owner whenever possible. Communication to the Case Owner related to an ICSR is completed through the routing comments in the Global Safety Database as needed

Job Requirements

•Degree level qualification (e.g. Bachelor’s degree) or above in scientific/medical field
•Healthcare professional (e.g. RN, Pharmacist, etc.) preferred
•Minimum 2 years of experience in Pharmacovigilance including ICSR processing
•Excellent database and coding skills (i.e. experience with MedDRA) including ability to perform advance searches
•Argus knowledge preferred
•In depth knowledge and understanding of clinical development
•Critical thinking and decision making skills
•Ability to review, analyze and interpret complex data to a high standard

Remuneration & other details

•Competitive salary
•Office based – Cambridge
•Permeant Position

Apply for this job: Safety Specialist I - Submissions

Contact Information:

Address:  DOCS UK
2 Globeside, Globeside Business park Marlow
Reasons to work for Docs International
Tel:  +44 (0) 2380 688500
Fax:  +44 (0) 2380 688501
Website:  Visit Our Web Site

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