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.

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 internal processes.

Compliance & Risk Management – Ensure all records meet established quality processes and complete thorough risk assessments for product quality issues.

Training, Mentoring & Squad Support – Develop and deliver training on vigilance/safety/PMS topics. Onboard and coach less experienced colleagues, contribute to agile projects, and act as a proxy for the Principal Specialist when needed.

Qualifications & Experience

Education – Bachelor’s degree in Sciences and/or vocational training with equivalent related experience.

Experience – 3+ years in a regulated environment;

preferred experience in Quality Systems, Vigilance, and/or Safety.

Languages – Fluent professional knowledge of English required; knowledge of German is a strong asset.

Technical Savvy – Laboratory experience and/or strong IT skills highly preferred.

General Mindset – Proven success working in virtual, cross‑functional, and intercultural teams.

Leadership & Soft Skills – Demonstrated critical thinking and problem‑solving, resilience, confidence, excellent communication and technical writing, and negotiation skills.

Roche is an Equal Opportunity Employer.

📌 Safety and Reporting Senior Specialist of Post Market Quality (Madrid)
🏢 PVH (Tommy Hilfiger/Calvin Klein)
📍 Madrid