LTO Partner: Safety

Job description

·  Job facts

LTO Partner: Safety

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.

Our Commitments

“Better outcomes to more patients, faster.”

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Healthcare partners are ‘wowed’ when they work with us

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Our innovations are faster and bolder

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We provide services and products to better serve people

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Purpose is our primary motivator

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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:

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Flexible resourcing across fit-for-purpose teams to address specific needs and priorities

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Healthcare-driven focus through outcomes

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Consultation, individual empowerment & accelerated decision-making through decentralisation

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Customer focus through mutually beneficial partnerships

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Collaboration

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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 fulfills you, it enables you to be authentic and truly bring your whole self to work.

LTO Partner: Safety

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 listedin the appendixwith key activities and deliverables including:

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Management of Individual Case Safety Report (ICSR) from all relevant sources

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Safety Oversight of Studies and Programs, including MAPs and EAMSs

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Local PV activity classification and oversight of PV contracts

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Service Provider oversight

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Oversight of Risk Management Plan Implementation

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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.

Individuals should be operating in one or more of the following categories:

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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 healthcare professional or scientific degree is required.

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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 healthcare professional or scientific degree is required.

LTO Safety Partner

Responsibilities includes but not limited:

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Having oversight of AE reports being processed accurately and within required deadlines and ensuring that all reportable cases are submitted to the MHRA in compliance with their timelines

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Maximising the quality of information captured relating to ICSRs and ensuring that this is recorded accurately and in a timely manner and in accordance with global and local SOPs and related documents

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Ensuring that the appropriate method of follow up is used to obtain additional information from reporters when appropriate and ensuring that any issues/queries related to AE reports are resolved in collaboration with internal and external stakeholders

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Timely completion of coordination and support tasks including QC of the data entry and submission of ICSRs and workflow manager responsibilities

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Reviewing the quality of activities outsourced to UK-TCS and ensuring that this quality is maintained to a high standard

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Acting as a PV approver for MAPs, including the setup, maintenance, training and closeout of these programmes

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Reviewing clinical trial documentation and publications to ensure PV compliance and performing the analysis of safety data originating from locally managed studies/programmes

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Write and review safety reports and safety regulatory documentation and review safety data outputs for local signal detection

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Awareness of the Risk Management Plans (RMPs) and associated pharmacovigilance requirements. Acting as the RMP-IC back as required

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Oversight of reconciliation activities to ensure that they are completed accurately and on time

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Quality checks and oversight processes are created and maintained to ensure UK DSC compliance with internal and regulatory timelines, is responsible for the escalation of issues

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Ensuring that all queries, including the team inboxes, are assigned and actioned appropriately and in a timely manner

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Performing other PV and product safety related tasks as needed, or supports UK DSC team members in PV activities related to study and program oversight, management of aggregate reports, local PV agreements, safety communication, PV quality, service provider oversight and monitoring

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Acting as a local process owner/subject matter expert (SME), driving process improvements and oversight responsibilities within these areas. This includes the formulation of KPIs/metrics to track oversight within this area, making key decisions within this area; acts as SME during regulatory authority inspections and internal audits and a CSF (Clinical and Safety Finding) implementation responsible when assigned

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Organising, facilitating and providing training to internal and external stakeholders on safety-related processes and activities along with adverse event (AE) reporting requirements. Supports new starters in onboarding and training

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Actively partnering with the business in providing PV and product safety expertise and representation for new and ongoing activities which includes but is not limited to, Non-Interventional Studies (NIS), Interventional Clinical Trials (ICT), digital activities and activities requiring the spontaneous PV clause; support in the assessment of PV related activities and ensuring that the correct process is followed based on the classification

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Awareness of and compliance to laws, regulations and legislation, relevant industry codes and guidelines as applicable to the business

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Actively sharing knowledge and best practises within the team and mentors/coaches team members in their area of expertise as needed

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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.

Roche is an equal opportunity employer.
Safety Health and Environment & Facility Services, Safety Health and Environment & Facility Services > Safety Health and Environment

·  Who we are

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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.