Director, Safety Surveillance Biopharm
CurrentLeading a scientific Biopharm team and in parallel an administrative team servicing the entire Safety Surveillance UnitCompliance for the Novo Nordisk Biopharm portfolio for signal detection & safety reporting to Health Authorities (PBRER, DSUR, Addendum to Clinical Overview, Safety Updates, RMP and submissions) Develop and execute strategy across the Safety Surveillance Unit for requirements for Internal Signal detection & Management and external safety communication to Health Authorities with focus on benefit/risk assessment including international Data Monitoring CommitteesGrow Business by participation in due diligences for the Biopharm portfolioLeading department’s deliverables and compliance within legislation, guidelines, safety communication to Health Authorities and internal requirements across the entire Safety Surveillance Unit. This includes department/unit leadership and management ensuring people qualifications/educational plans, preparedness for external requirements, department/unit result bottom line