Global Head of Patient Safety Operations

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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 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.
• 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.
• 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.
• 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.
• Establishing and implementing best practice sharing in pharmacovigilance activities.
• In collaboration with PDS vendor management responsibles, developing and implementing operational sourcing strategies to optimize cost, capacity, quality, and performance.
• 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.
• Member of the PDS Leadership Team, contributing to the overall management of the PDS department.
• Identifying future talent needs and attracting talent.
• 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.
• 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.

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.
• 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.

Roche is an Equal Opportunity Employer.