Senior Safety Scientist/Associate Safety Director

Role Overview

• Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
• 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 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
• 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
• Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
• Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
• Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
• They will provide clinical medical expertise and decision-making, in areas where this is specifically required to support colleagues in PCS

Requirements

• Formal medical qualifications (e.g. MD; MB BS; MB ChB) and have post-graduate experience in one or more areas of clinical medical practice including in medical specialities/disciplines that are relevant to clinical safety and/or to the therapy/disease areas in which the company develops and markets medicines
• Qualified healthcare professional or Life Sciences graduate
• Understanding of GxP and regulated processes and end to end clinical trial lifecycle
• Strong orientation towards process improvement and cross-functional teamwork
• 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
• Fluent in Mandarin and English

Benefits

• Our culture encourages personal expression, open dialogue, and genuine connections
• Roche is an Equal Opportunity Employer.