Global Program Safety Lead/sr

vor 14 Stunden


Basel, Schweiz Novartis Vollzeit

**Sourcing Statement**

*Roles will be filled at level commensurate with experience and in the following locations: United States, Europe (Switzerland, Spain) and United Kingdom*

Therapeutic Areas include, but are not limited to: Immunology, Hepatology and Dermatology; Neuroscience; Ophthalmology; Oncology; BioPharma & Generics

769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

You will ensure optimal patient safety and will be responsible for the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management.

**Your responsibilities include, but are not limited to**:

- Providing expert safety input to the clinical development program for assigned projects/products, participating as an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)
- Developing, and overall responsibility for key internal Novartis safety documents: reviewing these documents regularly and updating as required (e.g. when significant new information is received). Ensuring that these, and all other project-related safety documents (e.g. DSUR, PSUR, RMP), are consistent in safety messages
- Responsibility 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, constituting and running the Safety Management Team (SMT); ensuring that this team reviews all medical safety data from various sources (e.g. pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process in an appropriate and timely manner
- Initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications
- Responsibility for responses to inquiries from regulatory authorities or health care professionals on safety issues. Leading the preparation of the safety strategy for health authority submissions, responses and strategy, in collaboration with other project team members

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you will bring to the role**:

- Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree is required

Vb>Global Program Safety Lead:

- +3 years clinical experience postdoctoral and +5 years’ experience of drug development in a major pharmaceutical company (of which 2 years should be in a global position)
- +2 years in safety at an operational or medical position, with experience in scientific analysis, clinical safety assessments and regulatory discussions on safety and risk management
- Experience with designing safety strategy required
- Experience in leading cross-functional, multi-cultural teams and of (safety or other) issue management
- Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
**Sr Global Program Safety Lead**:

- 5 years clinical experience postdoctoral
- At least 7 years progressive experience in drug

development in a major pharmaceutical company (of
which 5 years in a global position), including 5 years in
safety at a medical position
- Expertise in preparing or contributing to preparation of

clinical safety assessments and regulatory reports/submissions involving safety information - to
include NDA submission documents
- Strong experience in leading cross-functional, multicultural teams
- Experience with (safety or others) issue

management
- Experience in drug development, clinical trial

methodology, regulatory requirements, scientific
methodology, statistics and writing of publications
- Leadership skills including coaching, motivating,

and directing, and fostering teamwork

**Division**

Global Drug Development

**Business Unit**

CMO & PATIENT SAFETY GDD

**Country**

Switzerland

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Alternative Country 1**

Spain

**Alternative Country 2**

United Kingdom

**Alternative Country 3**

USA

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No



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