Senior Safety Scientist

United States of America, California, South San Francisco

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Purpose

 

The Senior Safety Scientist supports early and late phase development activities as a member of the safety team under the leadership of the Safety Science Leader (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. 

 

 

Job Responsibilities

 

     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:  Bachelor’s degree in healthcare related field or equivalent experience and 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

     (For roles in China) Fluent in Mandarin and English

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