Brand Safety Leader, MD - (TCO)

Job description

Job Description

Serves as Global Program/Brand Team (GPT/GBT) 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 formation of GPT/GBT through Life Cycle Management (post-approval)
2. Develops and is responsible for key internal Novartis safety documents from the formation of the
GPT/GBT through Life Cycle Management. 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 with one another
3. 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. Ensures that
this team appropriately reviews all safety data from various sources (e.g. pre-clinical, clinical trial data
presented by Clinical Trial Head (CTH) or Medical Scientific Expert (MSE), Pharmacovigilance Expert
(PVE), or Pharmacovigilance Leader (PVL), post-marketing, literature) throughout the development
process
4. Provides expert safety input to the clinical development program for assigned projects/brands
5. Provides expert medical input to trial and project level Drug Safety Monitoring Board activities for
assigned projects/products, as required, whilst remaining blinded
6. Is 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. Is responsible for responses to inquiries 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 Country Organization (CO) requests involving safety issues. Provides integrated safety
input into all regulatory documents required during active development. Ensures safety information
communicated to EU Qualified Person in a timely fashion
8. Facilitates 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 presents brand safety issues to internal Novartis Boards and other meetings as
required
10. Provides relevant input for GPT/GBT, Global Clinical Team (GCT) and Clinical Trial Team (CTT) Meetings
as needed
Major Activities (describe main activities)
Job Purpose (state in one sentence the overall objective of the role)
General
BSL_Version 4
11. Collaborates productively with colleagues from Clinical Research, Regulatory Affairs, Medical Affairs,
Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments
12. Provides support as needed for licensing activities, regulatory authority inspections and for
project/product recall activities
13. Attends Health Authority Meetings in person, as required
14. . Mentors junior CMO and Patient Safety personnel
15. Serves as and performs activities of Pharmacovigilance Leader as needed
16. Deputizes for Therapeutic Area Safety Leader (TASL) / Multi-Program Head (MPH) or Sr. BSL when applicable
Posting Title

Brand Safety Leader, MD - (TCO)

Desired profile

Minimum requirements

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 re- ports/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
Job Type

Full Time
Country

USA
Work Location

East Hanover, NJ
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

CMO & PATIENT SAFETY GDD
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.