Senior Safety Scientist / Associate Safety Director - Early Development

About the role

Roche is hiring a Senior Safety Scientist / Associate Safety Director for its Early Development portfolio in Beijing. Working under the matrix leadership of the Safety Strategy Leader (SSL) and with Portfolio Clinical Safety colleagues, the role covers the full drug safety lifecycle from early-phase studies through post-marketing, including case reporting, signal detection, risk management and regulatory submissions.

Key responsibilities

• Develop and maintain an expert understanding of the safety profile of assigned products and therapies, including disease context, competitor profiles and mechanisms of action
• Manage individual and aggregate case reporting (ICSR medical review, DSUR, PBRER)
• Handle signal detection and management, including STAR and ISMP maintenance, and contribute to safety assessments and drug safety reports
• Contribute to the product safety strategy and give drug safety input to the Clinical Development strategy
• Support risk management: CCDS, labeling documents (including the IB), risk communications, RMP and REMS
• Contribute to study management from a safety perspective (SMT/PET, PASS) across early phase to post-marketing
• Review safety data for IND, NDA, MAA and variation submissions and prepare the relevant filing sections
• Maintain safety sections of the Company Core Data Sheet and Reference Safety Information in the IB, and take part in iDMC/IMC meetings
• Present safety issues to the Drug Safety Committee, Development Review Committee and other review bodies, and author or contribute to scientific publications
• Act independently on study teams, take on specialised roles (e.g. functional business process owner, subject matter expert) and, under certain conditions, act as Safety Strategy Lead for assigned molecules
• Provide clinical medical expertise where required, including medical practice impact assessments and formal medical assessments of adverse events
• Train and mentor junior PCS scientists and lead medium- and high-priority projects

Required profile

• Formal medical qualification (MD, MB BS, MB ChB) with post-graduate experience in clinical medicine relevant to clinical safety and the company's therapy areas, or a qualified healthcare professional or Life Sciences graduate
• Preferred: board certification or eligibility and other post-graduate medical qualifications
• Typically 4+ years of clinical drug development experience in the biopharmaceutical industry or a related sector, including at least 2 years in a clinical drug safety role
• Fluent in Mandarin and English

Required skills

• Understanding of GxP and regulated processes and the end-to-end clinical trial lifecycle
• Application of complex data analysis and statistical methods to interpret scientific data
• Project management methodology and strong presentation skills
• Ability to train others and work with remote partners on a global team