Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
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 abetter tomorrow.
The Position
As aSafety 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.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
