Roche
Healthcare
(Sr)SafetyScientist/AssociateSafetyDirector
Neural analysis suggests this role is
optimal for Senior candidates.
“(Sr) Safety Scientist/Associate Safety Director at Roche. Skills: Safety profile development, Signal detection, Risk management, Clinical drug development. Develop safety profile understanding. Maintain safety profile understanding”
Industry & Context.
Complex data analysis; Interpret scientific data; Evaluate scientific data; Present scientific data
What They're Looking For.
Must Have
Formal medical qualifications, Post-graduate experience in clinical medical practice, Qualified healthcare professional, Life Sciences graduate
Nice to Have
Relevant Board Certification(s), Board eligible, Other relevant post-graduate medical qualifications, 4+ years clinical drug development experience, 2+ years clinical drug safety experience, Understanding of GxP, Understanding of regulated processes, Understanding of end to end clinical trial lifecycle, Orientation towards process improvement, Orientation towards cross-functional teamwork, Effectively work with remote partners, Apply complex data analysis, Ability to effectively train others, Application of project management methodology, Fluent in Mandarin, Fluent in English
What You'll Do.
Develop safety profile understanding
Maintain safety profile understanding
Develop expert understanding
Maintain expert understanding
Perform aggregate reporting
Perform signal detection
Contribute to safety assessment strategy
Contribute to safety assessment review
Contribute to drug safety reports
Contribute to product safety strategy
Provide drug safety input
Contribute to risk management activities
Maintain labeling documents
Manage risk communications
Contribute to study management
Perform SMT activities
Perform PET activities
Review study documents
Maintain study documents
Contribute to regulatory submissions
Prepare filing sections
Prepare submission packages
Prepare safety sections
Maintain safety sections
Participate in iDMC meetings
Provide input for iDMC meetings
Participate in IMC meetings
Provide input for IMC meetings
Support presentation of safety issues
Author scientific publications
Contribute to scientific publications
Manage safety responsibilities
Support safety science activities
Take on specialised roles
Provide clinical medical expertise
Provide medical decision-making
Interpret safety-relevant data
Define safety questions
Perform medical practice impact assessments
Determine clinical medical impact
Interpret non-clinical safety findings
Provide advice on risk-benefit balance
Make formal company medical assessments
Assess suspected causal relationship
Review clinical study development plans
Review study protocols
Ensure appropriate study design
Ensure appropriate risk management measures
Achieve clinical risk management aims
Demonstrate independence
Demonstrate high competence
Emulate Roche culture
Emulate Roche core competencies
Demonstrate behaviors consistent with values
Train junior scientists
Mentor junior scientists
Take on complex deliverables
Take on team leadership
Challenge embedded behaviors
Bring agile approaches
Hold self accountable
Hold peers accountable
How You'll Work.
Team & Collaboration
Collaborate with PCS colleagues; Work with remote partners; Cross-functional teamwork
Communication Scope
Written communication; Verbal communication; Presentation skills; Summarizing key considerations; Presenting decision points
Process & Methodology
Project management methodology
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position Under the matrix leadership of the Safety Strategy Leader (SSL) and in collaboration with Portfolio Clinical Safety (PCS) colleagues to: ● Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action) ● 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 ● Contributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS ● Contribute to regulatory authority submissions (Investi
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