Executive Director, Safety Operations

Position Summary

BeOne’s Global Patient Safety (GPS) leadership team seeks a seasoned professional to lead end‑to‑end execution, quality, and continuous improvement of global safety operations. The role oversees collection, processing, assessment, and reporting of individual case safety reports (ICSRs), safety operations in clinical trials, China pharmacovigilance activities, and safety systems. It also actively supports GPS’s operational technology strategy and provides deep technical knowledge.

• Oversee ICSR activities: manage data collection methods, ensure consistent data flow and distribution, maintain data convention standards, and guarantee compliant ICSR submissions globally.
• Ensure appropriate representation of serious adverse event (SAE) data in safety‑related reports for clinical trials and ensure compliance of safety operations activities in trials.
• Collaborate with internal and external stakeholders to operationalize and optimize safety reporting processes, including the Trial Master File (TMF) and Safety Management Operation plans.
• Supervise China post‑marketing safety operations: ensure compliance with adverse drug reaction monitoring and reporting, oversee risk assessment and control, and manage effective communication of drug safety information.
• Oversee safety database, safety reporting gateways, and data repositories; support technical activities and documentation for all safety systems.
• Develop and implement pharmacovigilance (PV) technology strategies and projects, enhancing PV technology footprint within GPS and aligning with organizational objectives.
• Develop budgets and investment strategies for new technology capabilities to support PV.
• Lead the GPS Safety Operations Team, including ICSR management, ICSR submission, trial safety operations, China post‑marketing safety operations, and safety systems.
• Recruit, retain, develop, and mentor safety operations staff; create and maintain policies, guidelines, and SOPs from a safety operations perspective.
• Participate in the review of pharmacovigilance agreements, oversee PV agreement execution, and support outsourcing and vendor selection strategies.

• MD, PharmD, RN plus a higher degree or international equivalent; or an equivalent combination of education and professional experience.
• 15 years of relevant experience, including 10 years in drug safety.
• Mastery of global safety regulatory requirements and proficiency in safety report processing and operational systems.
• Experience with signal recognition, statistical techniques, and trial methods.
• Previous management experience and process and systems management expertise.
• Clinical experience preferred; proficiency with Microsoft Office and technical safety systems such as ARGUS.
• Travel:
  International and domestic, up to 20% of the role.

• Annual salary range: $285,800 – $365,800.
• Benefits include Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.
• Eligible for discretionary equity awards and the Employee Stock Purchase Plan.

BeOne is a proud equal opportunity employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by law. All employment decisions are based on qualifications, merit, and business need.

Individuals who require reasonable accommodation in the job application process may contact .