Patient Safety Partner

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Roche Pharmaceuticals Job Purpose The Patient Safety Partner (Lead) is accountable for the implementation, maintenance and oversight of the local PV system for the assigned affiliate(s)/country(ies) and sets the strategic direction for patient safety including risk management within the Affiliate, ensuring alignment with IPS priorities and local business needs. Key Responsibilities General - Lead/facilitate APS strategy and planning to enable effective prioritisation for impact. - Collaborate strategically with the Country Cluster Lead, Safety Net, Affiliate PV Net, Patient Safety Operations, and affiliate leadership by leveraging country safety insights to determine priorities, shape organisational strategies, and influence regional and global decisions. PV System - Act as the local single point of contact for safety-related aspects, internally and externally, including the local regulatory authority. - (In Case of a formal requirement for a local QPPV/Local PV Officer): Local Qualified Person for Pharmacovigilance (QPPV): As the named and qualified point of contact, the Local Qualified Person for Pharmacovigilance (QPPV) holds responsibility for both establishing and maintaining the local PV system, and for guaranteeing adherence to local requirements mandated by the local Regulatory Authority. - Lead the design, implementation, and maintenance of local PV processes and PV oversight ensuring they are effective and efficient, while driving continuous improvement and alignment with evolving needs and requirements globally and locally. Ensure appropriate escalation and action taken in case of compliance gaps. - Enable operational excellence and maintain oversight of safety-related activities relevant to the PV system through collaboration with key stakeholders such as Patient Safety Operations and Affiliate PV Net, by ensuring that day-to-day operations are executed effectively and efficiently to maintain the monitoring of the safety profile of Roche medicinal products and medical devices and their safety risk management, meet regulatory requirements, and ensure license to operate. Key areas of oversight/activities include: - Individual Case Safety Reports (e.g. data collection and submissions to HA) - Signal Detection & Signal Management for Local Products - Aggregate safety reports (e.g. submission to HA) - Pharmacovigilance Agreements (e.g. PVA, Safety Data Exchange Agreement) - Risk Management and Safety Communication (e.g., Direct Healthcare Professional Communication, Risk Minimization Measures, emerging safety issues) - Studies, Programs and other projects with PV implications (e.g., ICT, NIS, PASS, PAES, MAP, PAA, CUP, PTAP, Dicela) - Safety Labeling and PV Commitments - (Local) Pharmacovigilance System Master File - Lead in shaping country PV regulation and the broader country pharmacovigilance ecosystem according to APS grouping, in particular in order to promote regulatory reliance and international harmonization in partnership with pharma trade associations, healthcare organizations, patient groups etc. - Ensure business continuity and coordinate APS resources across the Affiliate to ensure appropriate prioritization and resource allocation to deliver key focus areas and outcomes. Local Safety Risk Management - Lead safety solutions implementation and launch readiness activities: Drive the implementation of global safety solutions locally within the integrated therapeutic strategy, and ensure that patient risk management needs are addressed by implementing relevant safety launch readiness activities. - Identify, analyze and share safety insights by understanding disease areas (Roche portfolio, patient journey), engaging with key stakeholders and APS team members, and ensuring timely, proactive integration into Affiliate and global strategies. - Lead safety risk management and external safety communications: Implement risk minimization strategies and ensure transparent, timely safety communication to healthcare professionals, patients, and external stakeholders, in partnership with Medical Affairs and the cross-functional team. - Strengthen cross-functional and cross-country collaboration: Foster strong cross-functional partnerships and represent affiliate safety interests in IPS forums, strategically influencing cross-country initiatives and implementing global solutions into local clinical practice. Further responsibilities may include assuming additional roles (e.g. RMP IC, Safety Responsible for DiCELA and MAP, core or extended member of the Affiliate Safety Disease Area Communities-ASDACs, Disease Area Expert, PV System Expert). Education/Qualifications - Degree in life science or healthcare-related discipline (e.g., MD, PharmD, PhD, MSc, etc.) - MD/HCP qualification is not a prerequisite, however, profile & qualification must meet local expectations (laws, regulations, stakeholders demands, etc.). Experience - At least 3-5 years experience in clinical research, development, or related field; including a minimum of 3 years in PV or Safety at the affiliate and/or regional level. - 3+ years experience collaborating or leading in global and local matrix environments, including proven ability in stakeholder management and influencing - Experience and expertise in decision-making in the local & global PV Ecosystem - Experience and expertise of relevant PV and medical device regulation - Experience in interaction with Health Authorities - Advantage: Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global functions such as Clinical Safety - Advantage: Matrix or VACC leadership with proven track record Competencies - Strategic Leadership & Planning: Able to develop and lead comprehensive long-term strategic plans; shape PV Strategy based on analysis and insights; solve unique challenges; pro-active, creative and strategic mindset. - Leadership & Collaboration in PV and Disease Areas: Strong leadership and collaboration skills in matrix teams; handle multifaceted challenges; lead efforts in people development and competency building; resolve complex compliance challenges. - Influencing & Negotiation: Strong influencing, negotiation, and partnership skills; influence policies to enhance the patient journey. - Patient & Environmental Focus: Deep understanding of the local environment; customer-centric mindset with understanding of patient journeys and health systems. - Knowledge, Learning and Technology: Knowledge of new developments in Disease Areas and/or PV; simplify complex knowledge; adopt new technology (Digitization, AI, automation). - Adaptability & Continuous Improvement: Agility to thrive in a dynamic environment and support transformational change. 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.