Director, Safety Science & Pharmacovigilance

BeOne Medicines USA, Inc.; United States; On-site; USD 185,100 - 245,100; Full time

Benefits offered by this job

Equity awards

Annual bonus eligibility

Comprehensive benefits

Job summary

BeOne Medicines USA, Inc. seeks a Director, Safety Scientist to lead safety signal identification, evaluation, and risk management across compounds. The role partners with PSLs and cross-functional teams to ensure regulatory-compliant safety deliverables and strong scientific leadership.

You will drive safety governance, prepare responses to health authorities, and mentor the Safety Science group while ensuring timely communication with stakeholders and adherence to global regulations.

Qualifications

• Pharmacovigilance/science leadership with 8+ years in related field.
• MD/PharmD/PhD level education with regulatory experience preferred.
• Experience with safety signal detection, DSURs, SMC/DSMB processes.

Responsibilities

• Lead safety signal evaluation and risk assessment across programs.
• Prepare and present safety data at governance meetings.
• Lead safety sections of regulatory submissions (IND/CTA, NDA/MAA).
• Author safety plans, inquiries responses, and regulatory artifacts.
• Provide pharmacovigilance training and mentor teammates.

Skills

Leadership

Communication

Regulatory interactions

Prioritization

Analytical thinking

Cross-functional collaboration

Education

PharmD/NP/RN/PhD plus 8+ years

MD plus residency or equivalent

Tools

Argus

MedDRA

Veeva

Excel/PowerPoint/Word

Spotfire/PowerBI

Job description

BeOne Medicines USA, Inc. seeks a Director, Safety Scientist to lead safety signal identification, evaluation, and risk management across compounds. The role partners with PSLs and cross-functional teams to ensure regulatory-compliant safety deliverables and strong scientific leadership.

You will drive safety governance, prepare responses to health authorities, and mentor the Safety Science group while ensuring timely communication with stakeholders and adherence to global regulations.