Associate Safety Director - Welwyn Garden City, United Kingdom - CK GROUP

CK GROUP
CK GROUP
Verified Company
Welwyn Garden City, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

CK Group are recruiting for a Associate Safety Director to join a pharmaceutical company in a hybrid home and office-based role with the offices based in Welwyn on a 12-month contract basis.

Role is outside of IR35

The main purpose of the role will be to:

  • Take responsibility for individual and aggregate case reporting activities including ICSR case management (medical review) and writing aggregate reporting (DSUR, PBRER)
  • Look after signal detection and management activities, contributing to the strategy and review of safety assessments and drug safety reports for signals or issues
  • Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy

Further responsibilities will include:


  • Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, authoring RMP, and REMS
  • Authoring or contributing to scientific publications (abstracts, posters, papers) for scientific meetings/journals
  • Acting independently to manage safety responsibilities on study teams and in activities supporting safety science

Your Background:


To succeed in this role, you will come from a Life Science background with drug development experience in the pharmaceutical or related industry including extensive Clinical drug safety/pharmacovigilance experience.


  • Understanding of GxP and regulated processes and end to end clinical trial lifecycle
  • Author/Write Aggregate reports such as PSUR, DSURs, PBERs and IBs

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54629 in all correspondence.
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