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Associate Safety Director – Senior Safety Scientist
RocheProviding clinical safety and pharmacovigilance support across Roche's portfolio. Leading post-market safety activities and influencing product safety strategy with minimal supervision.
About the role
Key responsibilities & impact- Contribute to shaping the future of healthcare by providing essential clinical safety and pharmacovigilance support across the entire Roche portfolio
- Serve as a key member of the safety team, offering crucial safety oversight and input into all aspects of study management from development through post-market
- Lead critical post-market safety activities, including signal evaluation, benefit-risk assessment, and comprehensive safety risk management
- Take ownership of individual and aggregate case reporting, encompassing ICSR case management and critical aggregate reporting activities like DSUR and PBRER
- Drive signal detection and management, contribute to the strategic review of safety assessments and drug safety reports
- Influence product safety strategy and provide vital safety input into the overarching Clinical Development strategy
- Contribute significantly to risk management by preparing and maintaining CCDS, labeling documents (including the IB), risk communications, RMP, and REMS
- Act independently with minimal supervision, demonstrating strong self-leadership, and proactively identifying and pursuing areas for personal and professional development.
Requirements
What you’ll need- A relevant post graduate qualification PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post-graduate health professional qualifications would be advantageous
- Demonstrate a strong understanding of GxP, regulated processes, and the end-to-end clinical trial lifecycle
- Exhibit excellent communication skills, both written and verbal, capable of effectively collaborating with remote partners on a global team
- Adept at applying complex data analysis and statistical methods to evaluate, interpret, and present scientific data with clarity
- Possess strong presentation skills, effective at summarizing and presenting key considerations and decision points to diverse audiences
- Proven ability to act independently and with minimal supervision, managing safety responsibilities on study teams and supporting clinical safety activities.
Benefits
Comp & perks- health insurance
- flexible working arrangements
- professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancesignal evaluationbenefit-risk assessmentICSR case managementaggregate reportingdata analysisstatistical methodsclinical trial lifecyclerisk managementsafety risk management
Soft Skills
communication skillsself-leadershipcollaborationpresentation skillsindependenceproactive identificationprofessional development
Certifications
PhDMScMedical qualificationPharmD