Clinical Safety Director Welwyn, England
Job description
Who we are
We are an innovative, curious and diverse company with 80,000 professionals in 150 countries. As a global leader in research-focused healthcare, we’re constantly learning and growing and seeking people who share the same ambitious vision.
We support our staff in the development of their knowledge and skills. Further local and global career opportunities are offered to people who demonstrate talent and aptitude.
Purpose
Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.
The Portfolio Safety Scientists (PCS-Sci) supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.
You will be expected to work with minimal supervision and apply strong self-leadership as well as identify areas of development.
Job Responsibilities:
Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
Responsible for signal detection and management activities. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including the IB), risk communications, RMP, REMS
Contributing to study management from a safety perspective through Study Management Team activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SPL
Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.
Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
Act independently to manage safety responsibilities on study teams and in activities supporting safety science
Take on the responsibility for specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
Education, Skills and Experience (Minimum)
Qualified healthcare professional or Life Sciences graduate.
Drug development experience in the pharmaceutical or related industry including within a drug safety or a closely related field.
Understanding of GxP and regulated processes and end to end clinical trial lifecycle
Strong orientation towards process improvement and cross-functional teamwork
Effectively work with remote partners on a global team
Excellent communication skills, both written and verbal
Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
Ability to effectively train others on departmental practices and processes
Application of project management methodology
This role will be based in our UK headquarters in Welwyn Garden City, just north of London. You can view our Site Fly Through Video here: - https://www.youtube.com/watch?v=Gd6OOU9CAP4
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. There is a fully equipped gym on-site, a library and information center, 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.
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. Every role at Roche plays a part in making a difference to patients’ lives. If you want to work in a passionate team, make your mark and improve lives, apply now.
Good luck with 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.
