GLOBAL PROGRAM SAFETY LEAD

Summary -Designs & develops safety surveillance strategy for products and approval.
Responsible for the company’s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.
Participates in the resolution of any legal liability and complying with governmental regulations.
Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle.
Provides safety support to the clinical development teams.
About the Role The Global Program Safety Lead successfully serves as scientific safety leader of the Medical Safety organization to improve patients’ lives and impact on overall Novartis results through robust safety evaluation expertise and medical innovation.
Ensures optimal patient safety for assigned compounds, is responsible for the integration, analysis, and interpretation of internal and external safety information from all sources through lifecycle management.
Your key responsibilities, but not limited to; Providing expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT).
Responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
Develop and is responsible for key internal Novartis safety documents.
reviews these documents regularly and updates as required (e.
.
when significant new information received).
Ensures that these, and all other project-related safety documents, are consistent in safety messages.
Own the safety strategy and document it in the corresponding documents (e.
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dSPP, SSPT) and leads the production of the medical safety deliverables (e.
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DSUR, PSUR, RMP) for the assigned products.
Responsible 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, constitutes and runs the Safety Management Team (SMT).
Ensures that this team appropriately and timely reviews all medical safety data from various sources (e.
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pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process.
Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities.
Responsible for 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.
Responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues.
Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members.
Ensuring safety information is communicated/escalated to HPS/MPH, HMS HYD and/or EU Qualified Person in a timely fashion.
Facilitate involvement of external experts (e.
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authors of white papers, members of trial- specific data safety monitoring boards, ad-hoc support for HA meetings, etc.) Preparing and presents safety issues to internal Novartis Boards and other meetings as required.
Provides relevant input for SMT/SMB, GPT, GCT and CTT meetings as needed Initiate and maintains productive cross-functional Medical Safety collaborations with colleagues within CMO&PS and those from other functions, e.
.
Clinical Development and Medical Affairs, Regulatory Affairs, Medical Information, Biostatistics, Quantitative Safety & Epidemiology, Clinical Pharmacology, QA, BD&L and NIBR, as well as externally with expert panels and other scientific contacts.
Languages.
Fluent in spoken and written English.
Understanding in another major language (e.
.
French, German, Spanish) desirable Education.
Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required.
Specialty Board certification desirable.
Useful additional degrees.
Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)