Brand Safety Leader

Novartis AG
France, Ile-de-France
Jul 2012
This job posting expired on September 3, 2012.

Minimum Requirements:

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 re-sponses 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.
Reference number: 94426BR