Associate Safety Director

Main Responsibilities:

• Develop and maintain expert knowledge of product safety profiles, disease contexts, competitor safety data, and mechanisms of action
• Lead medical reviews for individual case safety reports (ICSR) and aggregate reporting (DSUR, PBRER), including responses to regulatory inquiries
• Drive signal detection, assessment, and management, including strategy development for safety evaluations and drug safety reports
• Independently own risk management activities: develop and maintain Company Core Data Sheet, labeling documents, risk communications, and Risk Management Plans
• Review clinical trial materials (protocols, study reports, Investigator’s Brochure, ICF) to ensure alignment with safety strategies and risk management approaches
• Contribute safety science expertise to regulatory submissions
• Participate in and provide input to Drug Monitoring Committees (iDMC) and internal monitoring committees
• Assume specialized roles within the department, such as functional business process owner, subject matter expert, or safety committee member
• Coordinate and collaborate with external vendors supporting Safety Science functions
• Apply GxP standards, drive process improvements, and leverage complex data analysis to interpret and present safety findings

Your Profile:

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required
• Qualified 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)
• Associate Safety Director level and proven track record GxP & clinical trial lifecycle expertise
• At least 4 years of experience in drug development in the pharmaceutical or related industry
• At least 3 years in drug safety/PV or a closely related field
• IT/Tool Skills: able to extract data from the Safety Database and apply complex data analysis, and strong presentation skills
• Excellent communication skills and fluency in English, written and spoken