Senior Safety Scientist / Safety Science Associate Director
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.
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. The job holder will be expected to identify areas of development and complete the required training.
· 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
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.
Please consult with your line manager before making a formal application. Good luck with your application.