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14.01.2022

Global Program Safety Team Lead (80-100%)

  • 4051Basel
  • Festanstellung 80-100%

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Novartis bietet innovative medizinische Lösungen an, um damit auf die sich verändernden Bedürfnisse von Patienten und Gesellschaften einzugehen. Novartis, mit Hauptsitz in Basel (Schweiz), verfügt über ein diversifiziertes Portfolio, um diese Bedürfnisse so gut wie möglich zu erfüllen: mit innovativen Arzneimitteln, Produkten für die Augenheilkunde und kostengünstigen generischen Medikamenten. Novartis ist das einzige Unternehmen mit weltweit führenden Positionen in diesen Bereichen.
Novartis bietet innovative medizinische Lösungen an, um damit auf die sich verändernden Bedürfnisse von Patienten und Gesellschaften einzugehen. Novartis, mit Hauptsitz in Basel (Schweiz), verfügt über ein diversifiziertes Portfolio, um diese Bedürfnisse so gut wie möglich zu erfüllen: mit innovativen Arzneimitteln, Produkten für die Augenheilkunde und kostengünstigen generischen Medikamenten. Novartis ist das einzige Unternehmen mit weltweit führenden Positionen in diesen Bereichen.

Global Program Safety Team Lead (80-100%)

Job ID 334995BR Jan 14, 2022 Switzerland

Job Description

More than 52 different medical diseases! Novartis Global Drug Development portfolio includes a large number of innovative platform studies with more than 90 projects in clinical development, of which this safety position will play a key leadership role in supporting patient safety for breakthrough innovative medicines.

As our Global Program Safety Team Lead for BioPharma and Generics you will provide scientific and strategic leadership to optimize benefit-risk for assigned compounds.

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 will include, but are not limited to:

• Leading a team of global program safety leaders or medical safety leaders and will be accountable for overall safety strategy and deliverables for portfolio assigned to your team.
• Provide expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)
• Responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
• Develop and be responsible for key internal Novartis safety documents: reviewing these documents regularly and updating as required
• 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.
• Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities.
• Responsible for 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.
• Manage the responses to inquiries from regulatory authorities or health care professionals on safety issues.
• Lead the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members
• Contributing to and often leading the development of departmental and functional/business unit goals and objectives.

*Some restrictions to flexible working models may apply and will be discussed at interview if relevant

Diversity & Inclusion / EEO

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

Minimum Requirements

• MD required
• Proficiency in English (oral and written)
• Relevant experience within Clinical Trial Design, Data Review & Reporting Medical Safety Pharmacovigilance Benefit/Risk
• Demonstrated experience of managing a diverse team in a multi-country, matrix organization
• Board certification desirableDivision Global Drug Development Business Unit CMO & PATIENT SAFETY GDD Location Switzerland Site Basel Company / Legal Entity Novartis Pharma AG Alternative Location 1 Spain Alternative Location 2 India Alternative Location 3 Germany Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Apply to JobAccess Job Account

Arbeitsort:

4051Basel

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