Associate Safety Director
- Recruiter
- CK GROUP
- Location
-
Welwyn Garden City
East of EnglandUnited Kingdom
- Salary
- 80.00 - 100.00 GBP Hourly
- Posted
- 01 Feb 2023
- Closes
- 21 Feb 2023
- Job Title
- Associate Director
- Category
- Professional Services
- Contract Type
- Permanent
- Hours
- Full Time
CK Group are recruiting for a 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 IR35The 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
- 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
- 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
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