GLOBAL PROGRAM SAFETY LEAD - (CARDIO, RENAL, METABOLIC)

About the Role Primary Location.
Barcelona, Spain (hybrid) Alternate Location.
United Kingdom (remote) About this role.
As our Global Program Safety Lead within the CRM therapeutic area you will provide scientific and strategic leadership to optimize benefit-risk for assigned compounds.
Ensuring optimal patient safety and ownership for the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management.
This role will work directly with the Medical Safety Development team and reports to the Head Patient Safety CRM.
Key Responsibilities.
• Providing expert safety input to the clinical development program for assigned projects/products, participating as an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT) • Developing, and overall responsibility for key internal Novartis safety documents.
reviewing these documents regularly and updating as required (e.
.
when significant new information is received).
Ensuring that these, and all other project-related safety documents (e.
.
DSUR, PSUR, RMP), are consistent in safety messages • Responsibility for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data and other sources.
To this end, constituting and running the Safety Management Team (SMT); ensuring that this team reviews all medical safety data from various sources (e.
.
pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process in an appropriate and timely manner • Initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications • Ensuring responses to inquiries from regulatory authorities or health care professionals on safety issues.
Leading the preparation of the safety strategy for health authority submissions, responses and strategy, in collaboration with other project team members Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements Essential Requirements.
• Medical Degree preferred, (PhD, PharmD or equivalent graduate level health care professional degree will also be considered) • Sufficient clinical experience postdoctoral and extensive experience of drug development in a major pharmaceutical company • Safety experience in an operational or medical position, with experience in scientific analysis, clinical safety assessments and regulatory discussions on safety and risk management • Experience with designing safety strategy required • Experience in leading cross-functional, multi-cultural teams and of (safety or other) issue management • Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications • Fluent English (both spoken and written) Desirable Skills.
• Proficiency in Spanish is an advantage Closing date for applications.
26 January