AddressAs the Senior PV Process Director, you’ll be a senior member of the SEP (Scientific Enablement and Processes) organisation providing lead principal subject matter expertise for the design, development, maintenance & support of core safety processes, specifically the Signal Management Process.
The Senior PV Process Director is aninfluential role in continuous improvement and ongoing process innovation in the safetyarena at Roche. You’ll play a leading part in this key enabling andstrategic role, ensuring that Roche can continue to deliver effective scientific safety activities & PV system activities, in line with regulatoryauthority and internal stakeholder requirements.
Your key responsibilities
Serving as a Global Process Owner for assigned processes, ensuring effective design, development, and maintenance.
Acting as the lead subject matter expert, collaborating with cross-functional teams and anticipating future requirements.
Identifying and promoting good practices and innovation, ensuring process continuity and alignment.
Collaborating closely with Scientific Enablement Leaders to drive scientific innovation and enablement.
Building and strengthening relationships within Roche and with partners.
Leadingexpert working groups or committees to support processes or improvement programs.
Influencingexternally and promoting Roche activities.
Maintaining expert knowledge of regulatory changes and best practices.
Collaborating with internal governance bodies/stakeholders to adapt processes to business needs and requirements.
Developing business case proposals for improvement programs.
Providing leadershipin promoting continuous improvement and innovation.
Providing inputinto project prioritisation and capacity management activities.
Defining critical process requirements for associated tools and technologies.
Providing leadership in communication, training, implementation, and feedback related to processes.
Promoting a culture of continuous improvement and solution-oriented mindset.
Networking with internal and external groups to understand needs and find collaborative solutions.
Demonstrating the ability toinfluence stakeholders and resolve conflicts effectively.
Your profile
You hold an MD or a degreein a life science or healthcare-related discipline (e.g. PharmD, nursing, dentistry, etc), with strong relevant experience in pharmacovigilance and a clinical safety-related role.
You have strong expertise in Signal Management, ideally with experience leading signal management strategies.
You have demonstrated ‘hands on’ experience of delivering safety and PV activities, as well as solid knowledge of regulatory PV requirements and guidelines published by the major global Health Authorities (e.g. FDA, EMA, MHRA, etc).
You’re familiar with pharmacoepidemiologyand its potential application to safety related activities.
You have excellent written and verbal communication skills and the ability to present and critically discussclinical datain relation to its significance and impact on the core safety processes in both internal and external discussions.
You’re organised and self motivated, with good attention to detail & priortisation skills.
International business travel up to 15% of the time may be required
Your application
Please upload only your current compelling CV and/or Cover Letter.
This role is open in the UK at our Welwyn site, or in Switzerland at our Basel site.
We look forward to receiving your application!
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.
Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. 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.
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.
