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

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)

Associate Safety Director

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