Pharmacovigilance and Product Safety Expert

The Opportunity: The Regional PV Lead is accountable for driving the strategic evolution and transformative optimization of the Affiliate PV System across the assigned region, ensuring compliance and effectiveness. This position acts as a key contributor and expert in the Affiliate PV system in the region, fostering innovation across a complex, multi-country environment, in partnership with relevant regional and global stakeholders.The incumbent works as an extended team member of the Affiliate PV Net team, ensuring the exchange of critical learnings to inform and influence future global process design and refinement and proactively driving alignment of region-specific optimizations with the overarching global PV strategy.As the Pharmacovigilance and Product Safety Expert, you are responsible for: General: Architect, implement, and sustain structures and networked ways of working that enable the optimal use of resources within the IPS network, aligning with the APS grouping strategy. Lead/facilitate PV excellence strategy and planning to enable effective prioritization for impact across the assigned region. Collaborate strategically with the IPS Region Head, Safety Net, Affiliate PV Net, other PDS functions (e.g., Patient Safety Operations), and affiliate leadership by leveragingcross-country PV system insights to determine priorities, shape organisational strategies, and influence regional and global decisions related to the Affiliate PV system's robustness and effectiveness. PV system Champion PV stewardship and embed a proactive quality and inspection readiness mindset in safety-related activities. Strategize, coordinate, and manage change to support the effective implementation of global PV processes and local regulatory requirements across the assigned region in partnership with the Patient Safety Country Cluster Lead, APS, and Affiliate PV Net. Escalate compliance concerns to relevant stakeholders when necessary. Contribute where needed to GVP inspection readiness and management activities, in partnership with IPS/PDS, PDQ, and other key stakeholders, while proactively addressing potential PV risks and gaps. Affiliate PV system strategic leadership & transformation Serves as the key driver and recognized expert for the strategic evolution and transformative optimization of the Affiliate PV system internally and externally across the assigned region, proactively identifying and mitigating complex PV compliance risks and pioneering solutions that significantly enhance efficiencies and capabilities, setting new benchmarks for compliance, operational excellence Leverages deep, cross-country PV system insights (derived from e.g. PV processes implementation, advanced metrics, complex deviation analyses, and inspection/audit findings) to identify, anticipate, and strategically resolve complex country and regional-specific PV gaps, risks, and systemic process pain points, including those arising from intricate local interpretations or complex global and local regulations, ensuring high level of PV compliance and creating trust with regulators and patients. Architect, implement, and sustain the strategic transformation of the affiliate PV systems by identifying opportunities to strengthen PV system robustness and radically optimize affiliate PV processes. In partnership and alignment with the Affiliate PV Net, drives the co-creation and adoption of innovative, scalable solutions that significantly improve and optimize the Affiliate PV system across the region, fostering extensive cross-country collaboration and strategic resource flexibility to achieve measurable regional impact. Support in shaping country PV regulations and the broader country pharmacovigilance ecosystem according to APS grouping, in particular in order to promote regulatory reliance and international harmonization in partnership with the Regional PV Policy Lead, APS, and Affiliate PV Net. Lead initiatives to accelerate progress on Affiliate PV system-related IPS priorities in alignment with the Affiliate PV Net. Line Management and People Development Managing and developing multi-country Patient Safety Partners by: Demonstrating strategic leadership and appropriate resource flexibility and allocation functional recruitment, resourcing, and talent management strategies for the multi-country safety staff Identifying development needs and supporting capability building & succession planning Education/Qualifications Higher Degree in life science or healthcare-related discipline (e.g., MD, HCP, PhD, MSc, etc.) is preffered Who You Are" 10+ years of experience in PV, clinical research, development, or a related field, with a minimum of 5 years in affiliate PV or a global role focused on affiliate support is preferred Demonstrated expert-level experience in PV process design, strategic oversight, and continuous improvement for affiliate PV systems, including the successful implementation of large-scale initiatives 3+ years of experience leading and excelling in an extensive matrix environment, including proven ability in stakeholder management, influencing, and effective collaboration across cultures in a large global organization is preferred Profound experience and expertise in PV, with solid understanding of the pharmaceutical business and Roche portfolio. Well-versed in GVP, ICH-GCP, and other relevant standards and guidelines, as well as medical and safety aspects of FDA, EMA, and other relevant regulations 5 years minimum experience working/engaging with Health Authorities is preferred. 5 years minimum experience in process design and process-level oversight is preferred Proven expertise with a wide range of data/information: scientific/clinical, safety, legal/regulatory, medical writing, analytics, etc