A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement.
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Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings.
Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information.
Serves as scientific safety leader for assigned Novartis projects/products. Once the project team is formed, responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical through lifecycle management (post approval) and externally. 1. Responsible for safety issue management from end of Phase I (POC) through Life Cycle Man-agement.
2. Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, postmarketing data, and other sources.
3. Develops and updates, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant.
4. Leads Safety Management Team. Serves as safety representative on Global Program Teams (extended or core member)
5. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.
6. Responsible for responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Responsible for res-ponses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion.
7. Provides integrated safety input into all safety relevant parts of regulatory documents (ie IB, CDS, SCS, RMP, CO etc) required during active development, submission phase and during marketing phase.
8. Co-ordinates involvement of external experts (e.g. authors of “white papers”, members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.)
9. Prepares and may present project/product safety issues to internal Novartis Boards, or expert panels and other meetings
10. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
11. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
12. Serves as and performs activities of Pharmacovigilance Leader such as medical case review as needed.
Novartis is an Equal Opportunity Employer.
Medical Degree required. Specialty board certification desir-able. Ancillary degree in toxicology, pharmacology, or genetics useful. 3 years clinical experience postdoctoral
At least 7 years in drug development in a major pharma-ceutical company (of which 5 years in a global position), including 5 years in safety at an operational or medical po-sition
Experience in early clinical development/translational medicine and in due diligences
Experience in preparing of clinical safety assessments and regulatory reports/submissions involving safety informa-tion.
Track-record in leading cross-functional teams and people management
Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
Desirable: Management experience