Associate Safety Director

ppbMain Responsibilities: /b /p /p liDevelop and maintain expert knowledge of product safety profiles, disease contexts, competitor safety data, and mechanisms of action /li liLead medical reviews for individual case safety reports (ICSR) and aggregate reporting (DSUR, PBRER), including responses to regulatory inquiries /li liDrive signal detection, assessment, and management, including strategy development for safety evaluations and drug safety reports /li liIndependently own risk management activities: develop and maintain Company Core Data Sheet, labeling documents, risk communications, and Risk Management Plans /li liReview clinical trial materials (protocols, study reports, Investigator’s Brochure, ICF) to ensure alignment with safety strategies and risk management approaches /li liContribute safety science expertise to regulatory submissions /li liParticipate in and provide input to Drug Monitoring Committees (iDMC) and internal monitoring committees /li liAssume specialized roles within the department, such as functional business process owner, subject matter expert, or safety committee member /li liCoordinate and collaborate with external vendors supporting Safety Science functions /li liApply GxP standards, drive process improvements, and leverage complex data analysis to interpret and present safety findings /li pbYour Profile: /b /p libRelevant Swiss working/residency permit and/or Swiss/EU-Citizenship required /b /li liQualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant postgraduate qualification would be advantageous (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) /li liAssociate Safety Director level and proven track record GxP clinical trial lifecycle expertise /li liAt least 4 years of experience in drug development in the pharmaceutical or related industry /li liAt least 3 years in drug safety/PV or a closely related field /li liIT/Tool Skills: able to extract data from the Safety Database and apply complex data analysis, and strong presentation skills /li liExcellent communication skills and fluency in English, written and spoken /li