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Associate Safety Director

Welwyn Garden City, Hertfordshire   •  Contract/Temporary, Full time

CK Group are recruiting for an Associate Safety Director to join an outstanding global pharmaceutical company on a 12-month contract basis. This role is outside of IR35.

This role can be done remotely but you must be able to attend their office in Welwyn Garden City on ad-hoc basis when there is a business need.

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, labelling 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
  • Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
  • Author/Write Aggregate reports such as PSUR, DSURs, PBERs and IBs

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55219 in all correspondence.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 55219
  • Posted: 8th March 2023
  • Expires: 5th April 2023

CK Group

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