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
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 ourSafety 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.
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.
