BioTalent is collaborating with Big Pharma to appoint a permanent Associate Safety Director/Senior Safety Scientist who will span Safety in Clinical Trials to Post Marketing. This role will suit someone with a strong and successful track record in Clinical Trial Safety, defining/monitoring/managing risk, contributing to IB if it goes to filing, aggregate report writing, signal assessment, analysis of QCs and literature.

You will be Responsible For:

• Aggregate reports - ICSR, DSUR, PBRER
• Signal Detection, safety assessment, Risk management
• Response to regulatory authorities, submissions, NDA, MAA, IND etc
• Product safety strategy in relation to Clinical Development Strategy
• CCDS, labelling and maintenance of investigator Brochure
• Risk benefit analysis
• GCP, GVP/GPVP

You will bring the following:

• Medical qualification
• Patient facing experience before transition to industry
• Clinical drug development experience (hospital or CRO setting) and +2 years in Biotech/Pharma

If this role is for you please be in touch to dominic.pritchard@biotalent.com or +41415625046