Head Systems Operations Management, CMO & Patient Safety

Job description

Job Description

As Head Systems Operations Management, you will lead a global team to maximize Chief Medical Office & Patient Safety (CMO&PS) operational excellence and innovation through management of all IT systems, which are required for:

• Monitoring of safety profile of all Novartis medicinal products and medical devices
• Safety surveillance and signal detection, to guarantee safe use of all Novartis medicinal products and medical devices
• Compliant submission of individual case reports to health authorities

You will also lead continuous process improvement and process automation in CMO&PS vigilance systems, support a global user base and collaborate with many internal teams (Development IT, Regulatory Affairs, Clinical Development), and external technology and services business partners.

Major Accountabilities:
• Lead the Systems Operations Management global team of internal and external resources, and the related long-term strategy and team development plan
• Delegate Global Head of Technology & Systems Innovation when required
• Manage system operations for CMO&PS vigilance systems and databases
• Manage system life cycle (SLC) in collaboration with IT – system support and project delivery
• Collaborate with internal and external stakeholders to drive innovation and technology advancement, including representation in user groups for key systems
• Drive process automation to increase quality, efficiency and productivity
• Ensure pharmacovigilance inspection readiness and support inspections and audits as required
• Accountable for attaining or exceeding quality and operational metrics.
• Lead development and implementation of vigilance systems business continuity plans (BCP)
Position Title

Head Systems Operations Management, CMO & Patient Safety

Desired profile

Minimum requirements

Education: University Degree in Life Sciences, Information Technology or related subject
Languages: Fluent in spoken and written English. Understanding of another major European language (French, German, Spanish) preferred

Ideal background/skillset
• At least 10 years of experience in pharma drug development, ideally in patient safety
• At least 5 years of leadership experience in an international, cross-functional environment – including management of external providers
• Thorough understanding of systems operations, knowledge of Argus (preferred) or ARISg system administration and operation required
• Excellent understanding of patient safety, clinical development, quality and regulatory standards and policies relevant to CMO&PS functions, familiar with operational and scientific aspects of drug development
• At least 3 years of experience working within IT projects, with a thorough understanding of the issues revolving around aligning technology with business needs
• Experience supporting regulatory inspections, responding to inspectors and managing related team actions
• Strong interpersonal and leadership skills
Job Type

Full Time
Country

Switzerland
Work Location

Basel
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

CMO & PATIENT SAFETY GDD
Employment Type

Regular
Company/Legal Entity

Novartis Pharma AG