Director, Safety Science & Regulatory Strategy

BeOne Medicines; United States; On-site; USD 185,000 - 245,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

FSA/HSA

Paid time off

Wellness program

Equity awards

Job summary

BeOne Medicines is seeking a Director, Safety Scientist to lead safety signal detection, evaluation, and risk assessment across assigned compounds, partnering with Product Safety Leads and cross-functional teams to ensure regulatory compliance and timely scientific insights.

The role requires deep pharmacovigilance experience, strong leadership, and effective communication to interact with health authorities and internal stakeholders.

Qualifications

• PharmD, NP, RN, or PhD with 8+ years in Safety Scientist roles.
• MD with clinical training and 4+ years in pharma safety preferred.
• Strong knowledge of regulatory pharmacovigilance requirements.
• Experience leading safety submissions and regulatory inquiries.

Responsibilities

• Lead safety signal identification and evaluation to inform label changes.
• Define data acquisition strategies for safety assessments.
• Author and review safety sections of regulatory submissions.
• Lead governance presentations to Safety Management Team and DSMB.
• Mentor junior staff and coordinate cross-functional safety activities.
• Ensure compliance with global safety regulations and quality systems.

Skills

Signal analysis

Safety data evaluation

Cross-functional collaboration

Regulatory communication

Safety governance

Education

PharmD/NP/RN/PhD

MD with clinical training

Tools

Argus safety database

MedDRA

Office suite (Excel/PowerPoint/Word)

Veeva

Spotfire/PowerBI

Job description

BeOne Medicines is seeking a Director, Safety Scientist to lead safety signal detection, evaluation, and risk assessment across assigned compounds, partnering with Product Safety Leads and cross-functional teams to ensure regulatory compliance and timely scientific insights.

The role requires deep pharmacovigilance experience, strong leadership, and effective communication to interact with health authorities and internal stakeholders.