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

The Opportunity

Are you ready to look beyond a traditional job title and focus on where you can have the most profound impact on patient safety? 

As a Central Operations Lead within our Patient Safety Operations team, you will use your deep pharmacovigilance expertise to shape how safety data is processed and reported globally. You will join a forward-thinking environment where we actively connect people, processes, and data to ensure the highest standards of quality and regulatory compliance.

In this pivotal role, you will champion a quality mindset, driving proactive process improvements and leading complex initiatives with diverse stakeholders. From navigating rapidly evolving regulations to embracing cutting-edge tools like artificial intelligence with 'humans in the loop,' your insights will directly influence how we understand and communicate product benefit-risk profiles to protect patients worldwide.

• Oversee Service Providers: Drive effective relationship management and use data-driven metrics to oversee external partners executing ICSR tasks and Medical Device reports.

• Provide Subject Matter Expertise: Act as a trusted advisor, sharing your deep technical knowledge with internal colleagues, service providers, business partners, auditors, and regulatory inspectors.

• Lead Continuous Improvement: Proactively conduct comprehensive process reviews to design, co-create, and implement strategic process improvements and simplify workflows.

• Manage Compliance & Risks: Identify root causes of non-compliance to design and implement robust Corrective Actions and Preventative Actions (CAPAs), while transparently escalating risks to the BPO/GPO network.

• Evaluate Regulatory Impact: Conduct thorough impact assessments of new or updated international regulatory requirements across your assigned topics.

• Drive Complex Initiatives: Formulate and lead complex, time-pressured projects, collaborating across virtual and co-located matrix teams to meet customer needs.

Who You Are

• Pharmacovigilance Expertise: Deep knowledge of international regulations (such as ICH, EU GVP Modules, and FDA) and a solid understanding of the broader pharmaceutical industry and personalized healthcare environment.

• ICSR & Case Processing Knowledge: Profound, end-to-end knowledge of ICSR case processing, regulations, and stakeholder expectations.

• Proven Project Leadership: Demonstrated experience leading complex, fast-paced initiatives while managing a wide range of cross-functional stakeholders.

• Analytical Problem-Solving: A clear history of independent decision-making, issue containment, and risk mitigation.

• Flexible Learning Mindset: An undergraduate degree or equivalent on-the-job pharmacovigilance experience, alongside a passion for exploring new digital tools and regulations.

• Desirable Experience: Prior experience or knowledge handling Medical Device processing is highly advantageous.

Please note that this is a fixed term (12 month) CONTRACTOR/CONTINGENT POSITION. You will be employed by our 3rd party service provider.

Location: This position is based in Budapest. Relocation Assistance is not available

Who we are

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.