Global Program Safety Lead

vor 1 Woche

Basel, Basel-Stadt, Schweiz Novartis Vollzeit
391327BR

Global Program Safety Lead - Immunology:
Switzerland

About the role


The GPSL ensures optimal patient safety and leads the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management.

This position reports to the Head Patient Safety Immunology.

Key Responsibilities:

  • 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 projectrelated 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, postmarketing 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. preclinical, clinical trial data postmarketing, literature) throughout the development and postapproval 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:

  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Role Requirements

Essential requirements:

  • Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree is required
  • Sufficient clinical experience postdoctoral
  • Extensive experience of drug development in a major pharmaceutical company within a global role
  • Experience 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 crossfunctional, multicultural teams and of (safety or other) issue management
  • Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications

Division
Development

Business Unit
Patient Safety & Pharmacovigilance

Work Location
Basel

Company/Legal Entity
Novartis Pharma AG

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No

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