Director, Safety Scientist

BeiGene, Ltd.; United States; Remote; USD 179,000 - 240,000; Full time

Job summary

A leading company in the cancer treatment sector is seeking a Director, Safety Scientist. This role involves overseeing safety data analysis, regulatory reporting, and providing mentorship within the team. Candidates must possess experience in pharmacovigilance and strong leadership skills, with a competitive salary and comprehensive benefits offered.

Benefits

Health insurance

401(k)

Stock options

Wellness programs

Qualifications

• Experience with safety databases including Argus and MedDRA.
• Proficiency in Excel, PowerPoint, Word, and Veeva.
• Strong leadership and communication skills required.

Responsibilities

• Lead identification and analysis of safety signals.
• Oversee safety data review and contribute to protocol development.
• Analyze safety data for regulatory inquiries and reports.

Skills

Safety databases

Pharmacovigilance principles

Leadership

Organizational skills

Communication

Tools

Argus

MedDRA

Excel

PowerPoint

Word

Veeva

Spotfire

PowerBI

Job description

Director, Safety Scientist

Apply now: Remote (US) | Full-time | Posted: 30+ days ago | Job Requisition ID: R27364

BeiGene, Ltd. is in the process of rebranding to BeOne Medicines Ltd., pending shareholder approval, with a phased transition over 2025. During this period, both names may be used.

BeOne is experiencing rapid growth and offers challenging opportunities for experienced professionals passionate about fighting cancer. We seek scientific and business professionals who are motivated, collaborative, and share our dedication.

Job Summary:

The Director, Safety Scientist supports assigned compounds alongside Product Safety Leads, utilizing clinical and scientific expertise to detect safety signals, evaluate safety data, assess risks, respond to regulatory inquiries, and prepare reports. The role includes medical safety assessments and requires effective prioritization, critical thinking, and communication skills to ensure compliance with global regulations. This position represents GPS Safety Science globally and functions as a key member of relevant teams.

Key Responsibilities:

1. Safety Signal Detection and Evaluation: Lead identification and analysis of safety signals, define data acquisition strategies, perform safety data analysis, and communicate findings to stakeholders.
2. Clinical Trial Support: Oversee safety data review, contribute to protocol and regulatory document development, and lead investigator training.
3. Regulatory Reporting: Analyze safety data for regulatory inquiries and reports such as DSURs, PBRERs, and RMPs; respond to safety questions from health authorities and contribute to benefit-risk assessments.
4. Stakeholder Communication: Effectively communicate safety information internally and externally, including safety communication documents and safety governance meetings.
5. Leadership and Mentoring: Provide support and mentorship within the safety science team, and contribute to continuous improvement initiatives.

Supervisory Responsibilities:

May include direct reports, with leadership support in safety assessment and analysis activities.

Required Skills and Qualifications:

• Experience with safety databases (e.g., Argus), MedDRA, and signal management systems.
• Proficiency in Excel, PowerPoint, Word, Veeva, Spotfire, and PowerBI.
• Knowledge of pharmacovigilance principles, regulatory requirements, and clinical development.
• Strong leadership, organizational, and communication skills.
• Ability to manage multiple priorities and collaborate across functions.

Additional Qualifications:

• Experience in global regulatory interactions and matrix management.
• Understanding of human physiology, pharmacology, and disease states.
• Travel less than 10%.

Compensation and Benefits:

Salary range: $179,800 - $239,800 annually. BeOne offers comprehensive benefits, including health insurance, 401(k), stock options, and wellness programs.

Our Values:

We prioritize Patients First, Collaboration, Innovation, and Excellence. We value diversity and are an equal opportunity employer.