Senior Patient Safety Partner
Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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 aSenior 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.
- 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
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.
- 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.
- 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.
- 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.
- 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
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?
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100\.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik\-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
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