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Associate Safety Director

Welwyn Garden City, Hertfordshire   •  £0 - £100 per hour  •  Contract/Temporary, Full time

CK Group are recruiting for an 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 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 53645 in all correspondence.

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

  • Agency: CK Group
  • Reference: 54184
  • Posted: 1st August 2022
  • Expires: 29th August 2022

CK Group

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