For this new, strategic Technology Enablement Director position, we are looking for an experienced business leader who is an expert in pharmacovigilance (PV) enabling technologies, and who will be a key contributor to shaping and co-creating the future PV systems environment in collaboration with key business and IT stakeholders. We are in the process of implementing systems that include cutting-edge intelligent automation technologies with machine learning and artificial intelligence components.
Roche’s Product Development Safety Risk Management (PDS) organization enhances healthcare for patients by elucidating and communicating the safety profile of Roche medicines to optimize their benefit-risk profile.
The Pharmacovigilance Intelligent Automation and Business Systems Solutions (PVIS) group has overall responsibilities for business-owned safety systems activities, including business responsibilities of the evaluation, implementation and maintenance of technology solutions to enable business processes. It anticipates potential new enabling technologies, partners with industry and regulators, and identifies opportunities to test, deploy and incorporate new solutions into ways of working supporting the product lifecycle. PVIS Business System Owners areaccountable for maintaining the validated state of the PV systems complying with Computer System Validation (CSV) policy and processes.
PVIS is continuing its transformation towards an open, dynamic, transparent, inclusive, collaborative and agile work environment. PVIS members are committed to deliver faster and bolder innovations, making key contributions to help implement and maintain PV systems in support of the Roche Pharma Vision, embracing the Pharma Operating Principles. They are motivated by purpose and spend their time contributing where it adds the most value. PVIS members work flexibly in a flat hierarchy as part of empowered, self-managed, multi-skilled teams, organized in a “flow-to-work” model. They work collaboratively and share expertise across the organization to remove silos and duplication, and deliver solutions through agile ways of working and an agile mindset.
You are a thought leader and senior business expert in areas relating to pharmacovigilance (PV) enabling technologies and their requirements. As such, you are a key contributor to identify opportunities and co-create a pharmacovigilance systems strategy that pilots and implements efficient cutting-edge technology on new platforms, including intelligent automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies.
You are responsible for leading major global initiatives, programs and/or workstreams relating to the development and implementation of computerized systems supporting the company’s PV system, its various component processes, and their business oversight.
You possess advanced subject matter expertise in relation to critical PV and safety activities, in order to anticipate technology-related opportunities for PV and safety process-focused innovation and continuous improvements. You apply such expertise to develop both overarching strategies and/or specific proposals to improve or innovate in assigned areas of systems activity, across business process clusters, and in line with PDS and wider business goals.
You will anticipate potential new enabling technology opportunities and partnerships from the external environment that may be relevant to enabling PV activities and you will identify opportunities to test, deploy and incorporate new solutions into ways of working that support PV and safety related GxP activities. You collaborate closely with relevant counterparts across the Roche safety community (e.g. PV GPOs, PDSO & Safety Affiliate teams utilizing PV systems, etc.), with PD Informatics (PDIX) partners, and with wider Roche functions, as applicable, to co-create, design, pilot, test and/or implement the above.
You have expert knowledge of, and maintains an overview of, current and upcoming global and local PV regulations pertaining to data and technological requirements, and you are readily able to anticipate future systems needs based on PV technology trends in the Pharma industry, and more specifically the regulatory landscape pertaining to PV and GCP safety.
You collaborate with the Group Director PVIS, wider Roche Safety Community stakeholders and PDIX business partners to specifically define and maintain a strategic PV systems roadmap: Considering wider industry trends, emerging technologies and other innovation opportunities.
You influence wider business and IT stakeholders, including senior leadership levels, to drive cross-functional improvement and innovation of PV systems and technologies that support PV and GCP safety processes.
You focus on sustaining an active and collaborative network, including external collaborations with peer companies, industry organizations, system vendors and health authorities. You will typically represent Roche at relevant conferences and are likely to co-author relevant publications in your field. Furthermore, you may be required to represent Roche in relevant external initiatives that aim to establish standards or guidelines relating to the adoption of safety technologies (e.g. ICH, CIOMS, etc).
You will also act as a coach and expert adviser to Business System Owners and members of the PV Business Systems Solutions Director/Analyst job family across all PVIS business areas, and provide guidance on systems design and management.
You are also expected to act as a key advisor and contributor for strategic safety initiatives, programs and projects relating to PV and GCP compliance and quality, and represent PDS in relevant internal collaborations and committees.
Your Primary Responsibilities are:
Developing continuous improvement and innovation strategies, and related proposals, for the PV systems and GCP safety landscape, in line with Roche Safety focus areas and strategy, as well as wider PD, Pharma and corporate goals and ambitions
Ensuring that efficient cutting-edge technologies and platforms, like intelligent automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies are incorporated and maintained in collaboration with PDIX.
Establishing and maintaining strong relationships with key stakeholders internally and externally, to share new ideas and to anticipate changing customer requirements
Maintaining advanced subject matter expertise by staying current with global PV and GCP regulations, technology trends and commercially available system solutions that have to or can be applied to the Roche systems environment to remain in compliance with regulatory requirements and/or enhance PV processes and create efficiencies
Maintaining an overview and assessment of vendor solutions that are commercially available or in development
Initiating and evaluating POCs and pilots based on the above for possible fit in the PV systems environment
Contributing to establish and maintain a safety data governance framework
Leading full-scale projects or workstreams to innovate and/or enhance PV systems in line with agreed systems roadmap and business goals
Providing guidance and managing deliverables of other colleagues for specific projects or initiatives
Mentoring PV Business Systems Solutions Directors/Analysts and Business System Owners to strengthen leadership, systems related competencies and skills, and team effectiveness
Working closely with the PVIS Group Director, relevant Global Process Owners, Business System Owners and PDIX Business Partners, apply regulatory and technology expertise to define and co-create the safety compliance-critical aspects of overall system roadmap
Collaborating with PDS experts, other PD functions and PDIT to align and implement functional roadmaps and interfaces between PV compliance systems to reuse or share existing data and system functionality
Embracing and promotes agile mindset and agile way of working, and adjusting quickly to an environment with changing priorities, technologies and regulatory framework
Promoting a culture of continuous innovation and a solution-orientated mind-set in order to enhance and evolve PV systems
Providing relevant SME input to the communication, training, implementation, follow-up and feedback, relating to enabling PV system solutions
It is also possible in some circumstances that you may temporarily assume the Business System Owner role, where this required specific for new systems that are being development, until completion of the ‘go-live’ and hyper care phase, if needed
The above statements are intended to describe the general nature and level of work being performed by you. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required.
Education, Skills and Experience
Degree in life sciences, computer sciences or other relevant field, higher level degree preferred
Experience in pharmacovigilance is essential, with typically 10+ years of relevant systems related experience in pharmacovigilance, or closely related areas of clinical development
Experience in line or matrix leadership roles in a global organisation, with proven ability to deliver complex, cross-functional systems-related projects of high business importance/risk in an international and multicultural organization
Broad experience in a safety function and/or considerable exposure to PV activities, including collection, processing, reporting and analysis of pharmacovigilance data
In-depth understanding of key PV legislation, regulatory requirements and their implications with respect to the design, implementation and maintenance of PV systems
Highly developed communication, presentation and influencing skills, with the proven ability to establish effective collaborations across business units and to influence decisions without authority
Advanced strategic and analytical thinking skills, with the ability to rapidly assimilate complex information to inform decisions, and/or make effective business proposals in situations of ambiguity
Extensive expertise in the development of efficient software solutions to address complex business problems in a regulated and validated environment
Knowledge of database technologies, query and reporting tools, industry standard safety systems and medical terminologies, e.g. MedDRA
International business travel up to 10% of the time may be required, depending upon the business location of the jobholder and ongoing business project activities.