Global Program Safety Lead, Malignant Haematology
CDI Basel (Bezirk Arlesheim) Design / Civil engineering / Industrial engineering
Job description
Job Description
As a Global Program Safety Lead (GPSL), you will successfully serve as scientific safety leader of the Medical Safety organization. You will improve patients’ lives and impact on overall Novartis results through robust safety evaluation expertise and medical innovation. You will ensure optimal patient safety for assigned compounds and be responsible for the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management.
Main responsibilities:
• Provides expert safety input to the clinical development program for assigned projects/products and is an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)
• Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management
• Develops, and is responsible for, key internal Novartis safety documents, reviewing these documents regularly and updating as required. Ensures that these, and all other project-related safety documents are consistent in safety messages
• Owns the safety strategy and registers it in the corresponding documents (e.g. dSPP, SSPT). Leads the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products
• Is responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on input from all relevant line functions, post-marketing data, and other sources. To this end, constitutes and runs the Safety Management Team (SMT). Ensures that this team reviews appropriately, and in a timely manner, all medical safety data from various sources (e.g. pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process
• Documents, tracks & maintains records of the assigned compounds medical safety activities
• Develops and maintains safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications
• Responds to inquiries from regulatory authorities or health care professionals on safety issues. Leads the preparation of the safety strategy for health authority responses in collaboration with other project team members. Prepares safety data for Health Authority review boards (together with the clinical and biostatistical functions) and attends Health Authority Meetings in person, as required
• Responds to legal queries and Country Organization (CO) requests involving safety issues. Provides integrated safety input into all regulatory documents required during active development
• Ensures safety information is communicated/escalated to HPS/MPH, HMS HYD and/or EU Qualified Person in a timely fashion
Position Title
Global Program Safety Lead, Malignant Haematology
Desired profile
Minimum requirements
Education: MD preferred, PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable
Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) is desirable
Additional:
• 3 years clinical experience postdoctoral
• At least 5 years’ experience of working in drug development in a major pharmaceutical company of which 2 years should be in a global position
• Minimum 2 years in Safety, in an operational or medical position
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information
• Significant experience leading cross-functional, multi-cultural teams
• Demonstrated knowledge of (safety or other) issue management
• Experience of clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
Job Type
Full Time
Country
Switzerland
Work Location
Basel
Functional Area
Research & Development
Division
Global Drug Development
Business Unit
CMO & PATIENT SAFETY GDD
Employment Type
Regular
Company/Legal Entity
Novartis Pharma AG