Safety and Reporting Senior Specialist of Post Market Quality — Roche
- Location
- Sant Cugat del Vallès
- Contract
- full-time
- Posted
- 13 days ago
Role overview
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.
- 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.
- 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.
Main responsibilities
- 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.
Company and context
- As 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.
- 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.
Additional details
- Join Roche, where every voice matters.
- We do this today to build a better tomorr ow.
- Communication & Technical Writing: Excellent negotiation skills and the ability to author technical documentation tailored for regulatory authorities. A healthier future drives us to innovate.
Notes and original content
- The Position
- Communication & Technical Writing: Excellent negotiation skills and the ability to author technical documentation tailored for regulatory authorities.
- Who we are
- A healthier future drives us to innovate.
Questions about this listing
What salary does Roche offer for this role?
Roche lists CHF 85'500 - 129'500 gross per year for this position in Sant Cugat del Vallès. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Roche offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Roche during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Roche?
Use the "Apply now" button on this page — it links directly to Roche's original listing at roche.wd3.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
