Company
Healthcare
GlobalProgramSafetyLead
Neural analysis suggests this role is
optimal for Senior candidates.
“Global Program Safety Lead. Skills: Safety Science, Risk Management, Regulatory Compliance, Medical Strategy. Provide expert safety input. Be active member of Global Program Team”
What You'll Achieve.
Improve patients' lives; Impact on overall Novartis results; Optimal patient safety; Timeliness of safety analysis; Quality of safety analysis; Timeliness of interpretations; Quality of interpretations; Timeliness of presentations; Quality of presentations; Timeliness of communication; Quality of communication; Compliance with internal SOPs/WPs; Compliance with external regulations
Industry & Context.
Safety issue management; Signal detection; Signal evaluation; Signal interpretation; Safety analysis; Safety interpretations
What They're Looking For.
Must Have
Graduate level health care professional degree required, 3 years clinical experience postdoctoral, At least 5 years in drug development, 2 years in a global position, 2 years in safety operational or medical position, Experience preparing clinical safety assessments, Experience preparing regulatory reports/submissions, Experience leading cross-functional teams, Experience leading multi-cultural teams, Experience with issue management, Experience in drug development, Experience in clinical trial methodology, Experience in regulatory requirements, Experience in scientific methodology, Experience in statistics, Experience in writing of publications, Fluent in spoken and written English
Nice to Have
Medical Degree or equivalent preferred, Specialty Board certification desirable, Post graduate degree in Pharmaceutical Master of Public Health in Epidemiology, Understanding in another major language desirable
What You'll Do.
Provide expert safety input
Be active member of Global Program Team
Be active member of Global Clinical Team
Be active member of Clinical Trial Team
Develop internal Novartis safety documents
Review internal Novartis safety documents
Update internal Novartis safety documents
Ensure safety messages are consistent
Document safety strategy
Lead production of medical safety deliverables
Perform signal detection
Perform signal monitoring
Perform signal evaluation
Perform signal interpretation
Manage safety information
Constitute Safety Management Team
Run Safety Management Team
Review medical safety data
Document medical safety activities
Track medical safety activities
Record medical safety activities
Maintain safety information in Core Data Sheet
Address safety issues in labeling
Respond to regulatory authority inquiries
Respond to health care professional inquiries
Lead preparation of safety strategy for HA responses
Prepare safety data for HA review boards
Attend Health Authority Meetings
Respond to legal queries
Respond to Country Organization requests
Provide integrated safety input
Communicate safety information to HPS/MPH
Communicate safety information to HMS HYD
Communicate safety information to EU Qualified Person
Escalate safety information
Facilitate involvement of external experts
Prepare safety issues for internal Novartis Boards
Present safety issues to internal Novartis Boards
Provide input for SMT/SMB meetings
Provide input for GPT meetings
Provide input for GCT meetings
Provide input for CTT meetings
Initiate Medical Safety collaborations
Maintain Medical Safety collaborations
Provide expert medical input to DSMB
Provide expert medical input to DMC
Provide expert medical input to SAC
Perform tasks per applicable procedures
Keep working instructions up to date
Provide input to procedural documents
Ensure implementation of procedural documents
Support licensing activities
Support regulatory authority inspections
Support product recall activities
Lead day-to-day safety activities
Provide guidance to junior personnel
Engage in development of competencies
How You'll Work.
Team & Collaboration
Global Program Team; Global Clinical Team; Clinical Trial Team; Cross-functional Medical Safety collaborations; Colleagues within PS; Colleagues from other functions; External expert panels; Other scientific contacts; Cross-functional teams
Communication Scope
Safety communication; Presentations; Reporting
Process & Methodology
Issue management, Life Cycle Management
Full Job Description
**Job Description Summary** 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. **Job Description** Major Activities (Describe main activities) * 1\. Provides 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). * 2\. Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management. * 3\. Develops and is responsible for key internal Novartis safety documents: reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other project-related safety documents, are consistent in safety messages. * 4\. Owns the safety strategy and document it in the corresponding documents (e.g. dSPP, SSPT) and leads the production of the medical safety deliverables (e.g. DSUR, PSUR, RMP) for the assigned products. * 5\. Is 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.g. pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process. * 6\. Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities. * 7\.
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