Remote PVRM Safety Science Lead

Sumitomo Pharma America, Inc.; Oregon; Hybrid; USD 157,000 - 196,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision insurance

Paid time off

Job summary

Sumitomo Pharma America (SMPA) seeks a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs and collaborate across global development teams. You will guide SMT activities, ensure rigorous safety assessments, and support risk management strategies.

Preferred candidates will have substantial pharmacovigilance experience, and a strong track record in safety signal detection, aggregate reporting, and regulatory interactions with FDA/EMA and other authorities.

Qualifications

• Minimum of a bachelor’s degree in a healthcare, life science, or related scientific field.
• Minimum 6 years of relevant pharmacovigilance, drug safety, or related pharmaceutical/biotechnology industry experience.
• Experience in clinical development safety and aggregate reporting is preferred.

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance on key documents.
• Contribute to signal detection, safety monitoring, and communication of safety information.
• Review adverse event reports and support safety assessments and regulatory responses.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and Data Management.

Skills

Pharmacovigilance

Safety data analysis

Cross-functional leadership

Regulatory submissions

Communication

Project management

Education

Bachelor’s degree in healthcare or life sciences

Job description

Sumitomo Pharma America (SMPA) seeks a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs and collaborate across global development teams. You will guide SMT activities, ensure rigorous safety assessments, and support risk management strategies.

Preferred candidates will have substantial pharmacovigilance experience, and a strong track record in safety signal detection, aggregate reporting, and regulatory interactions with FDA/EMA and other authorities.