Director, Safety Scientist

BeiGene

Base: $185,100.00 - $245,100.00 annually; bonus/eq...
Signal and safety data evaluation
Regulatory reporting (dsur, pbrer)
Safety database (argus) proficiency
This role supports assigned compounds by leading the detection of safety signals and evaluating safety data to assess risks and benefit-risk profiles

Job Summary

  • This role supports assigned compounds by leading the detection of safety signals and evaluating safety data to assess risks and benefit-risk profiles.
  • The Director will author critical regulatory documents including DSURs, PBRERs, and Risk Management Plans while ensuring compliance with global regulations.
  • Candidates must possess advanced knowledge of safety databases like Argus and demonstrate strong leadership in cross-functional safety governance meetings.

Matching Summary

This role supports assigned compounds by leading the detection of safety signals and evaluating safety data to assess risks and benefit-risk profiles.

Salary

Base: $185,100.00 - $245,100.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Comprehensive package including Medical, Dental, Vision, 401(k), Life Insurance, and Paid Time Off

Skills & Requirements

Must-have

  • Signal and Safety Data Evaluation
  • Regulatory Reporting (DSUR, PBRER)
  • Safety Database (Argus) Proficiency
  • MedDRA Coding Knowledge
  • Clinical Trial Safety Monitoring
  • Benefit-Risk Assessment

Nice-to-have

  • Cross-functional Stakeholder Influence
  • Mentoring and Team Development
  • Innovative Process Improvement
  • Global Regulatory Agency Interaction
  • Data Mining Tools (Spotfire, PowerBI)

Key Requirements

  • PharmD, NP, RN, or PhD in medical/biological science
  • 8+ years experience as a Safety Scientist
  • MD plus accredited residency or equivalent clinical training
  • 6+ years pharmaceutical industry experience in Safety Science
  • 4+ years clinical experience in relevant therapeutic area

Work Rights

Not specified

Tailored Resume

Cover Letter