Safety & Reporting Specialist at Roche

Sant Cugat del Vallès, Catalonia, Spain -

Full Time

Start Date

Immediate

Expiry Date

13 Sep, 26

Salary

0.0

Posted On

15 Jun, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Case Management, Vigilance Reporting, Post-Market Surveillance, ISO Quality Systems, Regulatory Compliance, Risk Assessment, Change Management, Intercultural Collaboration, Data Monitoring, Technical Writing, Training and Mentoring, Agile Methodology

Industry

Biotechnology Research

Description

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 Who We Are At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. The Opportunity Are you ready to bring your structure, expertise, and passion for quality to a dynamic global environment? As our Safety and Reporting Specialist, you will join the Post-Market Quality (PMQ) team within Quality and Regulatory. In this role, you will work autonomously with minimal supervision, making key vigilance reporting decisions and driving compliance across one or more jurisdictions. You will be a crucial bridge between science, data, and regulatory bodies, ensuring our solutions remain safe and effective for patients worldwide. Your Main Responsibilities Case & Report Management: Take accountability for the timely and compliant handling of safety, vigilance, and Post-Market Surveillance (PMS) cases and reports, strictly adhering to ISO Quality System requirements, global regulations, and country-specific needs. Regulatory & Affiliate Collaboration: Interface with, prepare, and coordinate responses for Regulatory Authorities (e.g., FDA, Notified Bodies) and Affiliate Organizations. You will collaborate with subject matter experts to gather necessary information. Quality System & Process Improvement: Design and develop monitoring systems for data and PMS reports. You will review case quality and customer feedback to continuously optimize and streamline our processes. Compliance & Risk Management: Own the compliance of all records and cases with established quality processes, and take the lead in executing comprehensive risk assessments for product quality issues. Training, Mentoring & Communication: Deliver training on vigilance/safety/PMS topics and escalate unresolved issues efficiently. You will also participate in onboarding, coaching less experienced colleagues, and may act as a proxy for a Principal Specialist. Team & Project Support: Actively contribute to or lead agile projects (e.g., SQUADs), providing product teams with invaluable data from cases to update documentation and support product registrations. What’s in your toolbox? (Qualifications & Experience) To thrive in this role, you should bring a blend of technical capability and an intercultural mindset: Education: Bachelor’s degree in Sciences and/or vocational training with related experience. Experience: 0-2 years of experience working in a regulated environment. Experience in Quality Systems, Vigilance, and/or Safety is highly preferred. Technical & Lab Skills: Previous laboratory experience and/or strong IT skills are preferred. Languages: Fluent knowledge of English (and German is highly required/desirable depending on the specific jurisdiction). Mindset: Ability to work virtually and collaborate effectively within intercultural teams. A proactive attitude towards change management and continuous improvement. What we offer A vibrant, agile, and digital work environment where your ideas matter. Opportunities to grow within our TransformD framework and global networks. A competitive package and hybrid working model to support your work-life balance. 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The specialist is responsible for the timely and compliant handling of safety, vigilance, and Post-Market Surveillance cases in accordance with ISO and global regulations. They act as a bridge between science and regulatory bodies, managing responses to authorities and driving process improvements.