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Brand Safety Leader (POC)

Our exciting and very respected client in Switzerland is looking for a Brand Safety Leader to join their Development team on a permanent basis.

Key Responsibilities;

1. Responsible for safety issue management from end of Phase I (POC) through Life Cycle Management.

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 ICT Safety Subteam. Serves as safety representative on International Clinical Team (and IPT).

5. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.

6. Responsible for initial development and updates of safety information in Basic Prescribing Information (core global labeling), including addressing safety issues optimally in all project/product labeling claims.

7. 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 responses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion.

8. Provides integrated safety input into all regulatory documents required during active development

9. Reviews and provides integrated safety input into clinical study protocols and clinical study reports, including Brand Optimization studies

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. Prepares and may present brand safety issues to internal Boards and other meetings

12. Provides relevant input for IPT, ICT and TA Expert Panel meetings, as needed

13. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.

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 as needed.



Minimum requirements : Education (minimum/desirable):

Medical Degree required. Specialty Board certification desirable.

Useful additional degrees:

Post graduate degree in Pharmaceutical Medicine;

Master of Public Health in Epidemiology (or equivalent)

Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable.



Experience/Professional requirement:



� 3 years clinical experience postdoctoral

� At least 5 years are in drug development in a major pharmaceutical company (of which 2 years in a global position), including 2 years in safety at an operational or medical position-

� Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information.

� Experience in leading cross-functional, multi-cultural teams

� Experience with (safety or others) issue management

� Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications