The (Sr.) Safety Scientist supports early and late phase development activities as a member of the safety team under the leadership of the SSL providing essential safety oversight and input into all aspects of study management across the entire development portfolio. In the post-market setting, this role contributes to safety science deliverables required to maintain license to operate and to manage and communicate the evolving safety profile.
● Represent Safety Science with business process owners on processes executed by Safety Science
● Responsible for coordination and collaboration with vendors servicing Safety Science
● Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
● Trains and mentors more junior members of the safety team
● Takes on responsibility for more complex deliverables
● Takes on team leadership responsibility in order to manage and complete projects requiring more coordination and insight for low-medium priority projects
● Understands how safety activities contribute to development goals and takes measures to maximize safety value to the organization
● Takes on speaking opportunities and team leadership opportunities
● Demonstrates independence and high competence in the conduct of all safety science responsibilities
● Demonstrates behaviors consistent with Roche values and engenders confidence from senior management
In collaboration with the SSL:
● 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, and drug safety reports.
● Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
● Contributing to study management through SMT/PET and document review across the development continuum (early phase to post marketing studies), including PASS
● Interfacing with business process owners on processes executed by Safety Science
● Coordinate and assist in responding to Health Authority requests
● Responsible for supporting processes involving safety science such as the expected terms list, MedDRA baskets, ICF process, etc.
● Supporting product quality issues
● Responsible for carrying out activities related to quality system management for safety science
Education, Skills and Experience
● Minimum: Master degree and above in clinical medine, prefer M.D. or PhD degree in healthcare related field or 3 years of relevant experience.
● Work experience in pharma safety, pharmacovigilance or other related pharmaceutical development area
● 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
● Perform application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
● Fluent in Mandarin and English