Partner di sicurezza paziente senior — Roche

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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 Join Our Team: Senior Patient Safety Partner Are you a pharmacovigilance (PV) professional looking to make a strategic impact on patient safety? We are looking for a Senior Patient Safety Partner to drive excellence in our local PV systems and help shape the future of patient care. Job Purpose In this role, you will be the guardian of our local PV system for Spain. Your mission is to ensure we remain fully compliant with Roche global standards and local regulatory requirements, safeguarding our License to Operate. You will lead the execution of International Patient Safety (IPS) strategies, turning global solutions into high-quality local results. Key Responsibilities

• PV System Excellence: Partner with global and local teams to monitor safety profiles of Roche Products and manage their risks effectively.
• Operational Oversight: Manage critical PV activities including individual case safety reports, Pharmacovigilance Agreements (e.g. Safety Data Exchange Agreement), Risk Management and Safety Communication, Local Studies, Programs and other projects with PV implications (e.g., Interventional Clinical Trials, Non-interventional studies, Market Research Programs, Patient Support Programs, Compassionate Use Programs, Post Trial Access Programs, Digital Activities).
• Local Safety Risk Management
• Identify, analyze and share safety insights by understanding disease areas (Roche portfolio, patient journey), engaging with key stakeholders, and ensuring timely, proactive integration into Affiliate and global strategies.
• Implementation of safety solutions and launch readiness activities: Implement global safety solutions locally within the integrated therapeutic strategy, and execute product safety launch readiness activities.
• Risk management and safety communication: Support the country-level risk management strategy to optimize patient outcomes in collaboration within relevant networks and ensure compliant and transparent PV communications (e.g., DHPCs) to healthcare professionals, patients, and external partners in collaboration 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
• Regulatory Influence: Actively shape local PV regulations and ecosystems by collaborating with industry associations and health authorities. What You Bring
• Education: A degree in life sciences or a healthcare-related field (e.g., PharmD, Medical Doctor, Bachelor in Life Sciences, or Nursing).
• Experience:
• At least 5 years experience in pharmacovigilance, ideally in an affiliate setting
• PV Compliance Expertise: In-depth knowledge of global & local PV regulations and the ability to oversee comprehensive compliance monitoring systems.
• Decision-making ability in the local & global PV ecosystem
• Experienced in collaborating within global and local matrix environments, including proven ability in stakeholder management and influencing
• Advantage : Experience in other affiliate medical functions (e.g., Regulatory, Medical Affairs, Clinical Operations, Medical Information) or global functions such as Clinical Safety Core Competencies & Skills 1. Strategic Leadership & Big-Picture Thinking
• Strategic Planning: Ability to align complex projects with the company’s long-term goals.
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