Associate Safety Director

2 weeks ago


Welwyn Garden City, United Kingdom CK GROUP 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
- 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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