Clinical Safety Specialist
- Employer
- Barrington James
- Location
- London (Greater) (GB)
- Salary
- Comprehensive Package
- Start date
- 25 Jun 2021
- Closing date
- 25 Jul 2021
View more
- Discipline
- Clinical Research, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
My client a leading global CRO are looking for a Clinical Safety Co-Ordinator to join their diverse, collaborative and inclusive Safety team. The Clinical Safety Co-Ordinator will lead & contribute to the ongoing monitoring of Safety activities for assigned projects covering diverse therapeutic areas Across multiple developmental stages. If you are looking for an exciting role in a dynamic business, please read below…
Responsibilities
- Collect, process, and track serious adverse event (SAE) reports and clinical event documents
- Generate and track study report safety narratives
- Coordinate safety surveillance activities (e.g., lab review and trend analysis);
- Generate Investigator Safety Letters; and assist in preparation of clinical safety documents
- Collect outstanding information from investigational sites in order to update and close initial SAE reports
- Coordinate basic safety surveillance activities (e.g., laboratory review) including successful communication with Medical Monitor and Clinical Safety Manager
- Draft simple study-specific safety plans (i.e., Safety Monitoring Plan, Endpoint Management Plan) and documents (i.e., SAE forms, adjudication forms) for assigned studies
- Perform data entry of cases in EudraVigilance, as applicable
- Demonstrate comprehensive knowledge of GCP Guidelines and Sponsor Standard Operating Procedures
Requirements
- Bachelor’s degree and 1-2 years of clinical safety experience
- Demonstrate comprehensive knowledge of global safety regulatory requirements
- Demonstrate fundamental knowledge of medical terminology and Good Clinical Practice (GCP) Guidelines
If you are interested, get in touch with me ASAP…
Dan Hockaday
Pharmacovigilance & Drug Safety Recruitment Consultant
Email: Dhockaday (at) barringtonjames.com
Phone: 00441293776644
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
United Kingdom
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