Director, PS Data Operations & Analytics

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

The Director PS Data Operations & Analytics defines and executes the Sandoz Patient Safety Technology and Data Strategy in collaboration with colleagues and technology vendors within the Patient Safety Data Operations & Analytics group to ensure high performance of technology landscape, quality, and integrity of Sandoz Patient Safety Data. This includes leading the implementation of core Patient Safety Systems, and identification of opportunities for automation leveraging AI and Machine Learning technologies in close collaboration with Patient Safety Business Process Owners and key users to maximize business outcomes for Sandoz Patient Safety. Collaborates with operational technology teams in terms of understanding operational performance of the technology portfolio, to identify areas of improvement and simplification. This includes design and implementation of cross-functional processes, innovative technology solutions and Data Architecture for seamless data operability between systems in Sandoz to continuously improve and simplify Patient Safety organizational performance. Represents PS Data Operations & Analytics team during audits and inspections.
Supports a global client base and collaborates with many internal teams (Development IT, Regulatory Affairs, Clinical Development), and external technology and services business partners.

 

Job Description

Major accountabilities:

• Drives the definition and execution of the Global Sandoz Patient Safety Technology and Data Strategy

• Defines the Patient Safety Technology road map, project portfolio and master plan

• Leads the execution of key Patient Safety Technology projects through all phases from project definition, business case development, project planning, execution and hand-over to operations

• Develops and maintains Systems Strategy and road map in close collaboration with Patient Safety Business Process Owners, key users and Development IT, including Project Delivery

• Manages systems life cycle (SLC) of selected core Patient Safety systems in collaboration with IT; systems operations, configurations, Business Continuity Plans (BCP), including overseeing performance / governance of external service providers for IT systems

• Collaborates with internal, external stakeholders and vendors to drive innovation, automation and technology advancement, including representation in user groups for key systems

• Represents Head of PS Data Operations & Analytics on PV strategy, and operational issues. and in global / cross-functional process, performance or system related initiatives. Ensures pharmacovigilance inspection readiness and support inspections and audits as required.

• Interface with Health Authorities (HA) / external stakeholders, represent Sandoz on new safety regulations, safety and compliance issues and PV inspections. Work with internal functions to ensure compliance of Health Authority (HA) requirements.

Minimum Requirements:
Work Experience:

• At least 7 years’ experience in drug development in the area of Patient Safety and related Information Technology

• At least 5 years experience in Life Cycle management of critical business systems with a global user base

Skills:

• In depth understanding of core Patient Safety technology components and Data, such as Safety DB, Case In-take systems, HA Gateways etc, and opportunities for automation through novel technologies such as AI and Machine Learning

• Experienced in managing external vendors

• Thorough understanding of MedDRA, Disease dictionaries

• Experience supporting regulatory inspections, responding to inspectors and managing related team actions

• Strong interpersonal and collaboration skills

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

The future is ours to shape!

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.

 

Skills Desired

Clinical Research, Clinical Trials, Regulatory Compliance, Safety Science, Team Management