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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.
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.
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, 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 3-5 years experience in pharmacovigilance, ideally in an affiliate setting
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
Compliance Expertise: In-depth knowledge of PV regulations and the ability to oversee comprehensive compliance monitoring systems.
Advantage: Experience in other affiliate medical functions (e.g., Regulatory, Medical Affairs, Clinical Operations, Medical Information) or global functions such as Clinical Safety
Fluent English mandatory
Mandatory residence in Madrid
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?
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.