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Head of Technology, Patient Safety & Data Management (d/f/m) (80-100%)

Employer
Novartis
Location
Basel
Salary
Competitive
Closing date
Feb 28, 2023

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Sector
Pharmaceutical, Pharmacovigilance
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Job Description

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!

Are you ready to make a difference?

Job Summary/Purpose

In this role you will:

1) Lead a global team to maximize Patient Safety (PS) operational excellence and innovation through management of all IT systems, which are required for:
- Monitoring of safety profile of all Sandoz medicinal products and medical devices
- Safety surveillance and signal detection, to guarantee safe use of all Sandoz medicinal products and medical devices
- Compliant submission of individual case reports to health authorities
- Oversight of Vendor providing technology solutions

2) Lead continuous process improvement and process automation in PS vigilance systems.

3) Support a global user base and collaborate with many internal teams (Development IT, Regulatory Affairs, Clinical Development), and external technology and services business partners.

Your Key Responsibilities

Your responsibilities include, but not limited to:

- Leading the Systems Technology and data management global team of internal and external resources as well as leading the related long-term strategy and team development plan
- Ensuring all objectives for PS are met with regards to systems
- Developing and maintaining global and local IT systems, processes and procedures for PS, collection / follow-up of adverse events, and other safety information, as well as maintaining a well-functioning vigilance system and regulatory compliance with device vigilance regulations worldwide
- Managing system life cycle in collaboration with IT - system support and project delivery, including overseeing performance / governance of external service providers for IT systems
- Collaborating with internal and external stakeholders and vendors to drive innovation and technology advancement, including representation in user groups for key systems
- Driving process automation to increase quality, efficiency, and productivity
- Driving Global Sandoz pharmacovigilance (PV) strategy, PV system and worldwide compliance with safety regulations, interfacing with Health Authorities and external stakeholders ensuring pharmacovigilance inspection readiness and support inspections and audits as required
- Leading worldwide Patient Safety system application of uniform standards, policies, procedures, and metrics.
- Driving and managing change / adjustment of organizational structure and processes and leading development and implementation of vigilance systems and business continuity plans
- Owning team’s budget, contributing to talent and development, training, performance management, and optimal resource management

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

What you’ll bring to the role:
- Advanced degree (e.g. MS, MBA, PhD) in Life Sciences or Information Technology desirable
- At least 10 years industry (pharma drug development, ideally in patient safety) experience, broad experience in PV, knowledge of drug safety regulatory requirements
- At least 5 years of leadership experience in an international, cross-functional environment, management training and experience, strong interpersonal and leadership skills
- At least 3 years of experience working within IT projects, with a thorough understanding of the issues revolving around aligning technology with business needs
- 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 PS functions, familiar with operational and scientific aspects of drug development
- Experience supporting regulatory inspections, responding to inspectors, and managing related team actions
- Fluent in spoken and written English

Preferred Requirements:
- Clinical experience highly desirable
- Understanding of another major European language (French, German, Spanish) preferred

#orbit

Accessibility and accommodation (Switzerland only)
Novartis group is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Accessibility and accommodation (India only)
Novartis group is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could achieve here at Sandoz!

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