Associate Safety Director

  • Salary: Up to £100 phr
  • REF Number: 00053645
  • Consultant: Hendre Moolman
  • Contact: 01438 842970
  • Date Published: 13.05.2022
  • Sector: Pharmaceutical, Biotechnology
  • Location: Welwyn Garden City, London
  • Discipline: Pharmacovigilance

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 (also entirely remote based) on a 12-month contract basis. Role is outside of IR35

The Role: 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 ClinicalDevelopment 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

Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53645 in all correspondence.

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