Central Operations Specialist (PV, Pharmacovigilance)
Roche
Budapest, Unknown, Magyarország
Full-Time
Competitive
OfficeSenior
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 Opportunity
Are you ready to play a pivotal role in transforming how patient safety data is delivered globally?
As our Central Operations Specialist within Patient Safety Operations, you will be at the heart of our mission to ensure the efficient, high-quality, and compliant delivery of safety data outputs. You will process and report Individual Case Safety Reports (ICSRs) and device safety reports, via the utilisation of current/future safety systems, and use of vendor services, and co-develop innovative approaches for the transformation and reporting of wider types of safety-relevant data, beyond ICSRs.
In this dynamic role, you will collaborate closely with global vendors, business process owners, and cross-functional teams to maintain our inspection readiness and drive continuous improvements. You will have the unique opportunity to support change initiatives, explore cutting-edge technologies like artificial intelligence in pharmacovigilance, and guide our operations to meet both current and future regulatory requirements.
Oversee Safety Data Quality: Monitor workload, compliance, and quality across the global ICSR footprint to ensure internal and external performance standards are consistently met.
Manage Vendor & Process Collaboration: Support the oversight, coordination, and inspection readiness of ICSR and medical device safety activities in collaboration with external vendors and internal alliance managers.
Drive Continuous Improvement: Develop, maintain, and review metrics and KPIs to identify and execute process enhancements within safety reporting sub-processes.
Lead AI & Innovation Initiatives: Support the implementation of AI-augmented activities and human-in-the-loop interventions to optimize operational safety report delivery.
Provide Governance & Subject Matter Expertise: Act as a key point of contact for queries and issue escalations, supporting Case Processing Governance across Patient Safety Operations sites.
Support Regulatory Reporting Projects:Execute and coordinate regulatory reporting projects for Roche products by preparing documentation and ensuring adherence to established quality standards.
Who You Are
Industry Experience:A minimum of 2 years of relevant experience within the pharmaceutical industry, preferably with an emphasis on pharmacovigilance.
PV Knowledge: Strong working knowledge of global Pharmacovigilance regulatory obligations and compliance standards.
Project & Conflict Management: Proven ability to support or lead projects to a successful conclusion while demonstrating strong problem-solving and conflict-resolution skills.
Agile Mindset:Comfort working in a matrix environment, actively participating in or leading agile squads and sprints to deliver on business strategies.
Educational Background: A minimum of a degree-level qualification in a scientific or relevant field.
This position is based in Budapest, Hungary. Relocation Assistance is not available.
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.