Safety and Reporting Senior Specialist of Post Market Quality

Job 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 PositionAt 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 PositionAs a Safety and Reporting Senior Specialist of Post Market Quality, you will be a key player within our Quality and Regulatory organization. Working with a high degree of autonomy and minimal supervision, you will ensure our products maintain the highest standards of safety and compliance after they reach the market. You will dive into complex cases, collaborate globally, and contribute to continuous improvement in a dynamic, patient-centric environment. Your Main Responsibilities:Case & Report Management: Take accountability for the timely and compliant handling of safety, vigilance, and Post-Market Surveillance (PMS) cases/reports, strictly adhering to ISO Quality System requirements and country-specific regulations. Regulatory & Affiliate Collaboration: Interface directly with Regulatory Authorities (e.g., FDA, Notified Bodies) and Affiliate Organizations. Coordinate, prepare, and deliver precise responses by collaborating with global subject matter experts. Post-Market Surveillance (PMS): Maintain and facilitate the schedule of PMS reports, drive data generation, and lead the planning, completion, and evaluation of PMS activities for various product families. Quality System & Process Improvement: Develop advanced monitoring systems for data and PMS reports to boost efficiency. Review case quality and customer feedback to optimize our internal processes. Compliance & Risk Management: Ensure all records meet established quality processes, and take ownership of completing thorough risk assessments for product quality issues. Training, Mentoring & Squad Support: Participate in developing and delivering training on vigilance/safety/PMS topics. Onboard and coach less experienced colleagues, lead or contribute to agile projects (e.g., SQUADs), and act as a proxy for the Principal Specialist when needed. What’s in your toolbox? (Qualifications & Experience):Education: Bachelor’s degree in Sciences and/or vocational training with equivalent related experience. Experience: 3+ years of experience working in a regulated environment (preferred experience in Quality Systems, Vigilance, and/or Safety). Languages: Fluent professional knowledge of English is required. Knowledge of German is a strong asset. Technical Savvy: Laboratory experience and/or strong IT skills are highly preferred. Global Mindset: Proven experience working successfully in virtual, cross-functional, and intercultural teams. Leadership & Soft Skills that will make you thrive:Critical Thinking & Problem Solving: Ability to make sound decisions even when dealing with limited or ambiguous information. Resilience & Confident Manner: A strong sense of quality, a solution-oriented mindset, and the ability to adapt to changing environments. Communication & Technical Writing: Excellent negotiation skills and the ability to author technical documentation tailored for regulatory authorities. Who we areA 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.