Beschreibung

Associate Safety Director (m/f/d)
For a leading pharmaceutical company, we are looking for a qualified
Associate Safety Director (m/f/d)
General Information:
Location: Basel
Workload: 100%
Start: 
Duration: 12 months (Extension possible)
Home Office: First 3 months full on-site presence for training; afterwards, . 40%
Your Responsibilities:
Own and maintain an expert understanding of the safety profile of assigned product(s)/therapy area(s) and their strategic context (disease, MoA, competitors).
Lead case management and reporting activities: medical review of ICSRs and aggregate reports (e.g., DSUR, PBRER).
Drive signal detection and signal management, including safety assessments and responses to Health Authority requests (incl. quality-related safety topics).
Contribute to and help shape the product safety strategy, including benefit–risk considerations.
Independently manage risk management deliverables (e.g., RMP, CCDS, labeling/IB updates and risk communications).
Review key clinical documents (protocols, study reports, IB, ICF) to ensure alignment with the safety strategy and appropriate risk communication.
Provide safety-science input to regulatory submissions and governance/oversight forums (e.g., IND/NDA/MAA activities, iDMC/IMC, DSC/DRC), collaborating with SSLs, teams, and vendors.
Your Profile:
Qualified healthcare professional or Life Sciences graduate (postgraduate degree such as PhD/MSc/PharmD is an advantage).
More than 4 years drug development experience (pharma or related industry).
More than 3 years in drug safety/pharmacovigilance (or closely related field).
Minimum candidate level required: Associate Safety Director.
Strong Excel/Word/PowerPoint skills; able to extract data from safety databases and apply complex data analysis.
Fluent English (written and spoken)
Interested? Then apply today. We look forward to hearing from you! jidfbc09aca jit0626a jiy26a