(Sr) Safety Scientist/Associate Safety Director

About this role

<p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come

Join Roche, where every voice matters.</p><h3></h3><p></p><h3>The Position</h3><p>Under the matrix leadership of the Safety Strategy Leader (SSL) and in collaboration with Portfolio Clinical Safety (PCS) colleagues to:</p><p>● 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) </p><p>● Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER) </p><p>● Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance

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 </p><p>● Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy </p><p>● Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including the IB), risk communications, RMP, REMS </p><p>● Contributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum (early phase to post marketing studies), inclu

Apply for this role on Roche’s official careers site.