Posted on Mar 17, 2019 by Hobson Prior
The 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.
Represent Safety Science with business process owners on processes executed by Safety Science
Responsible for coordination and collaboration with vendors servicing Safety Science
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, labelling 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
Minimum: Bachelor's degree in healthcare related field or equivalent experience
Work experience in pharma safety, pharmacovigilance or other related pharmaceutical development area preferred
Appreciation of GxP and regulated processes and end to end clinical trial lifecycle
Strong orientation towards process improvement and cross-functional teamwork
Able to work with remote partners and teams across global sites
Excellent communication skills, both written and verbal
Understanding on application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
(For roles in China) Fluent in Mandarin and English
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life science recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.