Novartis

Overview In this role you will lead the Medical Safety organization within the CRM Therapeutic Area, shaping safety strategies across product lifecycles to advance patient outcomes. You will mentor scientists, drive cross-functional safety inputs for development programs, and manage safety information from discovery to post-marketing. By leading safety issue management and lifecycle activities, you help ensure high-quality regulatory submissions and global safety leadership. This is a high-impact, global leadership opportunity at Novartis in Basel.

Leistungen / Benefits flexible and hybrid working options minimum 14 weeks paid parental leave bonus opportunities insurance plans retirement plans wellbeing resources Verantwortungsbereiche Manage an efficient disease area within the CRM Medical Safety organization to support benefit-risk decisions across the product lifecycle Provide training and coaching to Medical Safety physicians/scientists; identify talents and support career development Contribute safety input to clinical development programs; participate in GPT, GCT, and CTT Lead safety issue management from GPT formation through lifecycle management Oversee signal detection, monitoring, evaluation, and appropriate safety information management Document and track safety activities; respond to regulatory inquiries on safety issues Lead development of safety strategy for health authority responses Contribute to departmental and

functional/business unit goals and objectives Zentrale Anforderungen Medical Degree or equivalent (required); PhD, PharmD or equivalent graduate degree desirable Minimum 5 years clinical experience postdoctoral At least 7 years of drug development experience in a major pharmaceutical company with 5 years in a global role, including 5 years in safety Strong experience in preparing safety assessments and regulatory submissions with safety data Substantial experience in leading cross-functional, multicultural teams Extensive experience in drug development, clinical trial methodology, regulatory requirements, statistics, and scientific writing Leadership Coaching and people development Cross-functional collaboration Safety signal detection and management Regulatory reporting and NDA submissions Clinical safety assessments and medical writing (RMPs, PSURs)