Senior Patient Safety Partner

About this role

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).

Requirements

• 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.
• System Thinking:
• Looks at the organization as a whole to get things done across different departments, breaking down silos and removing unnecessary bureaucracy or obstacles.
• Driving Strategy:
• Leads cross-functional teams and helps shape the direction of complex, high-impact projects.
• 2. Collaboration & Stakeholder Management
• Subject Matter Expert:
• Acts as a trusted advisor and safety expert within cross-functional teams and global networks.
• Stakeholder Management:
• Skilled at influencing and managing relationships with senior leaders, as well as building a strong network of internal and external contacts.
• Patient-Centric Solutions:
• Represents local patient safety needs and collaborates with partners to launch and implement innovative safety solutions that comply with local regulations.
• Growth Mindset:
• Thinks beyond the immediate role to find wider opportunities for impact, always ready to challenge the status quo to drive continuous improvement.
• 3. Problem Solving & Prioritization
• Complex Problem Solving:
• Guides teams to resolve difficult challenges that have major cross-functional impacts.
• Smart Prioritization:
• Successfully balances and aligns global corporate priorities with local country needs.
• 4. Knowledge & Learning
• Business & Clinical Acumen:
• Deep understanding of the pharmaceutical business, commercial development, regulatory compliance, and specific disease areas.
• Compliance Oversight:
• Takes full ownership of compliance by designing and supervising robust monitoring systems to solve potential regulatory challenges.
• Mentorship & Culture:
• Recognized as a thought partner who coaches and mentors colleagues to build high-performing teams and fosters a positive, continuous learning environment.
• Other requirements
• A high level of proficiency, both spoken and written, in the English language is a  prerequisite for this role. Candidates must be fully comfortable operating in an English-speaking professional environment.
• Mandatory residence in Madrid, Spain
• Mandatory Spanish and English fluent
• Why Join Us?
• You will be recognized as a thought partner and subject matter expert in a culture that values an "abundance mindset" and continuous learning. This is an opportunity to mentor colleagues, lead cross-functional teams, and contribute to a high-performing global safety network.
• Are you ready to lead the way in patient safety?

About Roche

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.