| || Serves as scientific/medical 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 Management.
2. Accountable 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. Accountable for developing and updating, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant. Accountable to ensure adequate risk management plans are in place.
4. Leads Safety Management Team.
5. Serves as safety representative as core member of Global Program Teams. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.
6. Accountable for responses to inquiries from regulatory authorities or health care professionals on safety issues. Accountable for safety data for health authority review boards. Accountable for responses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion. Co-ordinates product-specific activities.
7. Accountable for integrated safety input into all safety relevant parts of regulatory and company documents (ie IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, etc) required during active development, submission phase and during marketing phase.
8. Review of medical safety input into study protocols (including MRC and OPCE), MAP, RAP, and ICF.
9. Review/approve product-specific safety deliverables: IN letter, PGD, data searches, literature review, expert statements.
10. 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.)
11. Accountable for presentations on project/product safety issues to internal Novartis Boards, or expert panels and other meetings.
12. Collaborates productively and manages in a cross-functional matrix team environment (e.g. SMT).
13. Assist in training of new hires (e.g. new BSLs) and mentor/coach direct reports (PVL/PVE) as required.
14. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
15. Serves as and performs activities of Pharmacovigilance Leader such as ad hoc medical case review as needed.