LTO Partner - Safety & RMPIC
About Roche UK
We’re here to deliver better outcomes to more patients, faster.
That means the world to us.
Our achievements help to transform the lives of millions of people. We’ve been supporting patients for over 100 years in the UK, building a reputation that we’re intensely proud of. Through this success, we’ve set an incredibly high standard. Those expectations continue to grow. The environment in which we operate changes at an ever-increasing pace. The industry is never going to stand still.
As one united team at Roche UK, we know we need to boldly respond to these changes whilst keeping our customers and our patients at the heart of everything we do.
So, we’re shooting for the stars, transforming ourselves into a much more open, dynamic, transparent, inclusive, collaborative and agile business.
“Better outcomes to more patients, faster.”
- Healthcare partners are ‘wowed’ when they work with us
- Our innovations are faster and bolder
- We provide services and products to better serve people
- Purpose is our primary motivator
- We spend our time contributing where it adds the most value
… we ensure brilliance across the organisation
… we can feel brave, innovate and take calculated risks within legal and ethical boundaries...not fearing consequences if things “go wrong”
… we can bring our authentic selves to work
… we do not need permission. We take personal accountability and trust each other.
… we can develop our career based on our passion, experience & behaviour and play to our strengths
… we work within less hierarchy – and with more coaching
… everyone can be a leader, regardless of role
… we aim to spend 20% of our time on personal development
Our UK operating model is based on the following principles:
- Flexible resourcing across fit-for-purpose teams to address specific needs and priorities
- Healthcare-driven focus through outcomes
- Consultation, individual empowerment & accelerated decision-making through decentralisation
- Customer focus through mutually beneficial partnerships
- Transparent portfolio level prioritisation
Mindset and behaviour is as important to us as experience and capabilities.
We won’t tell you how to behave with detailed competency frameworks; we ask you to bring your differences so we can celebrate a more diverse and inclusive workforce.
We offer a starting point for you to consider and to reflect on what this might mean for you: we’re building a culture that is centered around growth mindset, prioritisation, ownership and accountability. We need individuals who are courageously authentic in their thinking and in their actions. This is what excites us about our future.
We believe that on-going personal transformation is the heart of on-going organisational transformation and that fundamental to this is knowing yourself.
For us, knowing yourself means being aware of your own strengths and weaknesses, your passions and fears, your desires and dreams, your thoughts and feelings, your likes and dislikes, your tolerance and limitations. Knowing yourself requires you to: regularly stop, pause and reflect as you change and develop over time, invite and share feedback regularly and know where to focus your development, know when to hold things lightly and what to let go of. Knowing yourself means knowing your purpose and what fulfils you, it enables you to be authentic and truly bring your whole self to work.
LTO Partner - Safety + RMPIC: Expectations
Individuals should be operating in one or more of the following categories:
- With a broad safety background and experience, you will have strong safety knowledge and contribute to foundation and/or squad based work as well as supporting the development of squad/chapter based plans and goals. May support the learning & development of other chapter members. A scientific degree or healthcare professional is required.
- With broad and comprehensive expertise within the Safety environment you will lead foundation work and partner with the business to solve complex safety issues that impact the chapter and/or wider business. Contributes to development of squad/chapter based strategic plans and goals. Actively contributes to the learning & development of other chapter members. A scientific degree or healthcare professional is required.
LTO Partner: Safety
The LTO Partner: Safety is responsible for maximising the potential of the pharmaceutical business by ensuring that external and global Safety requirements are translated simply into Roche policies & procedures and into practical & compliant solutions when partnering the business. Takes on responsibilities of a safety partner with key activities and deliverables including:
- Management of Individual Case Safety Report (ICSR) from all relevant sources
- Safety Oversight of Studies and Programs, including MAPs and EAMSs
- Local PV activity classification and oversight of PV contracts
- Service Provider oversight
- Oversight of Risk Management Plan Implementation
- Ensuring PV Quality
The Safety partners need to be adaptable to change and entrepreneurial in nature in order to identify opportunities, while maintaining a laser focus on ensuring compliance and therefore playing a key role in retaining Roche UK’s Licence to Operate.
LTO Partner: RMPIC
As per LTO Partner Safety and takes additional responsibilities of Risk Management Plan Implementation Coordinator for the UK:
- Acting as the Cross Functional Process Owner for the local implementation of RMPs
- Coordinating local Risk Minimisation activities
- Completion of Global RMP Trackers
- Acting as a Subject Matter Expert
- Documentation and training on RMP process
- RMP Implementation oversight across UK product teams
- DHPC implementation oversight
- Coordinate local PV and/or Risk Minimisation activities as specified in RMPs as well as activities to measure/evaluate the effectiveness of such measures and provide data to global safety teams.
- Timely completion of Global RMP Tracker (PLATO – Planning and Tracking Operations) Communicate RMP information in a timely manner (as per local SOP) to relevant functions for further action, follow up on execution and escalates as appropriate.
- Ensures that correct information for DHPC is submitted and agreed with the MHRA prior to local implementation so that distribution is done in compliance with the local regulations
- Ensures oversight on the implementation of DHPC communications and timely completion of relevant local and global trackers
- Contact relevant SSL in HQ through the IPV team with any RMP specific questions and feedback from MHRA regarding proposed RMinAs, and feedback information
- Subject Matter Expert
- Act as single point of contact for all RMP-related questions, activities and implementation both internally and externally
- Act as SME for UK on specific topics around risk management planning, e.g. Assessing the RM strategy and providing feedback on feasibility of proposed RMinA to global teams (assessments made in close collaboration with other relevant local functions)
- Provide on a regular basis an oversight report of all RMP-related activities to the Medical Director and Head of Safety & Quality
- Demonstrate oversight by collation of methodology and effectiveness measures
- Document process for local implementation of RMP and train relevant job roles within Rx UK
- Ensure training is provided on approved RMinA for relevant groups, including respective responsibilities. Proactive engagement with internal stakeholders to share oversight and best practice examples.
- Maintain up to date safety risk management knowledge and expertise in the operational implementation of RMP provisions
- Monitor and conduct impact analyses of local legislation in the RMP area and inform local and global teams as appropriate, including process development leaders
- Monitor adherence to the process of RMP implementation and alert Medical Director and General Manager in case of compliance issue
- Maintain oversight as the Functional Outsourcing Responsible for service providers performing RMP related activities
Reports to: UK Safety Section Lead
If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.
To be considered for this position, please apply using the link below.
When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.