Senior Safety Scientist
You will provide safety science and pharmacovigilance input to assigned molecules across the Roche portfolio and at all development phases from early through to post-marketing as a member of the Portfolio Clinical Safety (PCS) group.
Working in collaboration with the Safety Strategy Program Leader (SSL) as a member of a safety team for a molecule and/or PCS Management you will provide essential safety oversight and input into all safety related aspects of study management across the development portfolio as well as contribute to new drug applications / regulatory filings. In the post-market setting, you will monitor and communicate the evolving safety profile of Roche medicines and will contribute to the safety science deliverables that maintain our license to operate including signal evaluation, ongoing regulatory filings, benefit-risk assessment and safety risk management. You may also represent Clinical Safety as a subject matter expert (SME) for key processes.
As a Senior Safety Scientist, you will be supported by supervision from more experienced colleagues but are expected to work independently on less complex deliverables. You will be expected to continue learning about safety science and pharmacovigilance to develop your understanding of the contribution of safety activities to overall drug development goals.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
At minimum you will have a Bachelor’s degree in a healthcare related field or equivalent but a higher level education is preferred. Additionally, you will bring work experience in pharma safety, pharmacovigilance or other related pharmaceutical development areas. You will have a good understanding of GxP and regulated processes and end to end clinical trial lifecycle.
You will have a strong orientation towards process improvement and cross-functional teamwork, and will work effectively with remote partners on a global team. Your excellent communication skills will be complimented by an understanding of the data analysis and statistical methods required to evaluate, interpret and present scientific data clearly and concisely.
Please be advised that you require approval from your Line Manager before making a formal application. Good luck with your application.