Global Head of Patient Safety Operations
Roche
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The Position
Who We Are
The Product Development Safety (PDS) organisation delivers patient-centric solutions that build trust and create value for society, leading smarter safety design and decision-making activities throughout the lifecycle. PDS sustains Pharmacovigilance (PV) system compliance and quality, to foster trust and drive efficiency while innovating and improving the capabilities that address the evolving priorities of our enterprise.
The Opportunity
The Global Head of Patient Safety Operations is a pivotal role for the organisation and is leading the building and implementation of the Patient Safety Operations strategy, driving industry leading global and regional operational excellence. You will be accountable for the execution of key safety processes that are essential to meet regulatory requirements, aid scientific analysis and advance the delivery of patient centric safety. In this role you drive and strategically lead priorities for Patient Safety Operations across multiple locations supporting the overall PDS Strategy. You lead and empower the Patient Safety Operations team and ensure efficient, cost effective, high quality and compliant delivery of operational activities, establishing beneficial relationships with vendors supporting the Patient Safety Operations deliverables.
As the Global Head of Patient Safety Operations you will be a member of PDS’ leadership team, ensuring the effectiveness of PDS on a day-to-day basis and for impactful long term strategic programs.
Primary Responsibilities and Accountabilities
Delivery of above-country safety operational activities, ensuring consistent execution, globally and across regional hubs, including (but not limited to):
Leading Patient Safety Operations Teams responsible for Individual Case Safety reports (ICSR) and medical device safety report collection, processing, and reporting, including associated quality and training activities
Collaborating closely with stakeholders including International Patient Safety (IPS) Global Head and Regional Heads, Affiliate Safety Leaders to ensure operational requirements, and identification of further opportunities and innovation
Collaborating closely with Roche technology organisations and technology vendors to maximize technological performance while driving cost optimization
Working closely with the Global Process Owners and Business Process Owners to ensure up-to-date processes and procedures
Providing vigilance expertise on operational processes to stakeholders including clinical, development and marketing teams. Consulting on safety data collection obligations from all sources of Roche Pharma products and modalities, classification and assessment of global digital activities, review of eCRFs for clinical trials, PV approval for global Market Research and Patient Support Programs
Negotiating, implementing and establishing safety agreements (eg. PVAs, SDEAs, Safety Management Plans etc) with partners
Leading and guiding Regulatory Reporting Services Team accountable for contributing information to the global Safety Regulatory Document Preparation process
PDS performance standards within Patient Safety Operations moving towards quality and compliance as a competitive advantage:
Ensuring tasks are performed according to international regulatory requirements, internal standards and in alignment with PDS strategies
Achieving defined performance metrics for patient safety operations processes
Ensuring Patient Safety Operations function is inspection ready, assisting PDS and Pharma Development (PD) Quality during inspections and audits
Partnering with PD and Pharma stakeholders to set clear data standards for provision of information, facilitating high quality compliant safety data processing
Continuous improvement activities in pharmacovigilance, particularly in relation to safety operations processes:
Identifying necessary changes to policy, process or organisation to improve compliance, quality and efficiency, proposing changes to the Global Process Owner and/or PDS Leadership Team and/or Good Vigilance Practice Council, and driving implementation of agreed change
Establishing and implementing best practice sharing in pharmacovigilance activities and identifying and implementing continuous improvement activities in support of operational PV
In collaboration with PDS vendor management responsibles, developing and implementing operational sourcing strategies to optimize cost, capacity, quality, and performance by finding the right balance between internal and external resources
Continually assessing the Patient Safety Operations capability needs to ensure readiness for future requirements
Leading and managing Patient Safety Operations team:
Leading and inspiring the Patient Safety Operations organisation, indirect leadership to vendors supporting Patient Safety Operations across multiple locations and cultures
Role modeling as a leader and strongly influencing others beyond reporting lines to deliver meaningful outcomes and maximum impact
Member of the PDS Leadership Team, contributing to the overall management of the PDS department
Identifying future talent needs and attracting talent. Ensuring that team members are coached, trained and developed to maximize impact and the well-being of the team
Leading effective change management across Patient Safety Operations in support of the Safety Strategy
Having budget accountability for Patient Safety Operations
Effective running of PD Safety Risk Management:
Building and sustaining strong trustful relationships with Global Head Safety Risk Management, peers and other key stakeholders
Collaborating closely with Global Head International Patient Safety to ensure the operational requirements of Affiliate Patient Safety are met
Understanding deeply the key value drivers of a leading global Safety Risk Management function
Ability for a strong critical thinking, creating and shaping meaningful, deliverable actions
Anticipating potential issues, risks, opportunities, and actions to prioritise and focus, helping others do the same
Who You Are:
MD, PharmD, PhD, or other advanced degree strongly desired
Minimum scientific qualification: (MD, PhD, MSc or Bachelor’s Degree) in health care profession or relevant life science or nature science discipline
Extensive and many years of management experience in pharmaceutical safety, including a thorough understanding of safety operations and regulatory requirements, with a broad understanding of downstream activities (e.g. signal detection, evaluation and risk management processes), proven familiarity with global health authority Pharmacovigilance standards (eg FDA, EMA) and ICH regulations and guidelines
Demonstrated success in leading large teams, changing culture and delivering impact whilst managing budget and timelines
Proven track record in managing business process outsourcing vendors and relationships
Strong ability in successfully driving complex, cross functional projects and process improvements in a complex, global matrix environment
Deep sense for continuous improvement and excellence applying a sound strategic thinking capability
Profound relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
Strong change management experiences and leading transformation
Excellent written and verbal communication across all levels with demonstrated influencing and negotiation skills
Ability to operate objectively and independently as a leader and as a member of a team, as required
Willingness to travel internationally and work across cultures
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.