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Associate Safety Director New

4 months ago

Welwyn Garden City, United Kingdom Clearline Recruitment Full time

Our client is one of the top 100 companies to work for in the UK, and they are looking for an Associate Safety Director. This is a hybrid role, with travel to the office in Welwyn as and when required.

***

**Responsibilities**
- Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
- Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e., DSUR, PBRER)
- Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
- 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, labelling document maintenance (including the IB), risk communications, RMP, REMS
- Contributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
- Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
- Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
- In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.
- Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
- Acts independently to manage safety responsibilities on study teams and in activities supporting safety science

**Requirements**:

- Minimum Qualifications: Qualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous.
- Understanding of GxP and regulated processes and end to end clinical trial lifecycle
- Strong orientation towards process improvement and cross-functional teamwork
- Effectively work with remote partners on a global team
- Excellent communication skills, both written and verbal
- Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
- Ability to effectively train others on departmental practices and processes
- Application of project management methodology

**Job Title**: Associate Safety Director***

**Location**:Hybrid, office in Welwyn***

**Salary**:£80-£100/hour LTD/UMB, £59.67 - £74.58/hour PAYE basic***

**Full Time**:37.5 hours per week***

**Fixed Term Contract 12 months**

For more information, please contact Chloe McCausland at Clearline Recruitment.