Associate Safety Director
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.