Senior PV Quality Specialist

F. Hoffmann-La Roche AG; Welwyn; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Roche Products Ltd. is seeking a Senior Pharmacovigilance Quality Specialist to lead quality activities within Pharmacovigilance and Quality Management Systems.

You will support license-to-operate activities, develop process documentation, training packages, and collaborate with Global stakeholders to ensure patient safety and regulatory compliance. The role requires involvement in GVP/GCP/MDR inspections, PV continuity, and process improvement.

Qualifications

• Experience in pharmacovigilance, clinical safety or medical device vigilance, with quality activities.
• Knowledge of regulatory requirements related to quality management systems.

Responsibilities

• Process management: develop and update procedural documentation and records to meet regulatory requirements.
• Training management: design and implement training materials and learning approaches.
• Stakeholder collaboration: build relationships with Global & Business Process Owners and Quality teams to align on quality approaches.
• Inspection readiness: support GVP/GCP/MDR safety audits and inspections, especially document requests.
• Participate in PV System Master File management, PV Compliance Monitoring, CAPAs and related processes.

Skills

Quality experience

Collaborative

Analytical

Self-motivated

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 Position Senior Pharmacovigilance (PV) Quality Specialist Are you ready to lead and inspire in a dynamic role at Roche? As a Senior Quality Specialist, you will play an important role in Roche's Pharmacovigilance and Quality Management Systems: your mission will support delivery of the highest standards of patient safety and regulatory compliance. Join us to make a significant impact by supporting key license-to-operate activities, such as functional process development and training activitiesGood pharmacoVigilance Practice (GVP)/Good Clinical Practice (GCP)/Medical Device Regulation (MDR) Safety audits and inspections, and fostering a culture of continuous improvement.

Key Responsibilties

• Process Management: development and update of procedural documentation, working with key stakeholders to streamline processes and enhance quality outcomes as well as meeting regulatory requirements, and maintaining accurate records of the process landscape for the PV system
• Training Management: design and development of training packages, working with key stakeholders to define and implement the most appropriate learning approach and materials
• Stakeholder collaboration: build and maintain relationships with key stakeholders (e.g. Global & Business Process Owners, Quality) to align on quality approaches for specific process documentation and training activities
• Inspection readiness: Supporting activities relating to the conduct of GVP/GCP Safety/MDR audits and inspections, specifically in the area of document request management.
• Other processes in which our team plays a key role include: Pharmacovigilance System Master File management, PV Compliance Monitoring, GVP Business Continuity Management, Business Risk Management, and management of the deviations/findings and Corrective and Preventive Actions (CAPAs) process; you may also have the opportunity to become involved in these processes.

Who you are

• Quality experience: Experience in pharmacovigilance, clinical safety or medical device vigilance related area(s) including quality-related activities; experience in process mapping / development and/or training development is essential, together with knowledge of key regulatory requirements, in particular those relating to quality and quality management systems.
• Collaborative and results driven: You enjoy building strong relationships with your global stakeholders; you collaborate and influence effectively to deliver quality and results in a matrix environment.
• Analytical and process-focussed: you can process and manipulate data as well as analyse and report information to stakeholders effectively, to facilitate decisions and knowledge sharing
• Passionate and self-motivated: You are independent and well organised, with good attention to detail, and can work simultaneously on complex and/or multiple projects/activities with excellent time management skills.

Location

This position is based in Welwyn Garden City, UK. Our team follows a hybrid work structure, requiring a fixed number of onsite days per week. Relocation Assistance is not available

Who we are

A 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.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work. We believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And 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. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.