PVRM Safety Scientist Lead - Remote US

Sumitomo Pharma; Santa Fe (NM); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America seeks a Senior Manager, Pharmacovigilance Scientist to lead safety governance and SMT activities across programs. You will guide safety evaluations, support regulatory submissions, and ensure consistent risk management across development and marketed products.

The role emphasizes cross-functional teamwork with Clinical Development, Regulatory, Biostatistics, and Data Management to maintain robust safety oversight and timely risk communication.

Qualifications

• Minimum of a bachelor’s degree in a healthcare, life science, or related field.
• Minimum 6 years of pharmacovigilance, drug safety, or related experience.
• Advanced degree preferred; oncology/neurology exposure beneficial.
• Experience leading cross-functional activities, programs or projects.

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance on documents.
• Contribute to signal detection, monitoring, evaluation, and communication of safety information.
• Maintain ongoing safety monitoring for assigned products and support benefit-risk assessment.
• Collaborate across Clinical Development, Regulatory Affairs, Biostatistics and Data Management.
• Lead or participate in aggregate safety reporting and regulatory responses.
• Review adverse event reports and assist in the preparation of safety documents.
• Support preparation of ISS/SCS, risk-mitigation strategies, and SOPs.

Skills

Pharmacovigilance

Drug safety

Signal detection

Safety data analysis

Cross-functional collaboration

Leadership

Regulatory submissions

Education

Bachelor's degree in healthcare or life science

6+ years pharmacovigilance experience

Advanced degree preferred

Job description

Sumitomo Pharma America seeks a Senior Manager, Pharmacovigilance Scientist to lead safety governance and SMT activities across programs. You will guide safety evaluations, support regulatory submissions, and ensure consistent risk management across development and marketed products.

The role emphasizes cross-functional teamwork with Clinical Development, Regulatory, Biostatistics, and Data Management to maintain robust safety oversight and timely risk communication.