Senior Pharmacovigilance Scientist – Remote Safety Leader

Sumitomo Pharma; Olympia (WA); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs. The role involves cross-functional collaboration with development teams and partners to evaluate safety signals, review reports, and contribute to regulatory submissions.

Ideal candidates have at least 6 years in pharmacovigilance, strong leadership, and experience in oncology/neurology safety.

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
• Prior experience leading cross-functional activities, programs, or projects strongly preferred

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance and input to key documents
• Contribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information
• Maintain ongoing monitoring and assessment of safety profiles for assigned products
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions
• Review adverse event reports to support interpretation and quality across safety assessments
• Coordinate responses to ad hoc safety issues and regulatory requests
• Develop and contribute to SOPs and risk-management documents
• Support inspection readiness and compliance initiatives
• Foster a Patient First culture within SMPA

Skills

Pharmacovigilance

Safety governance

Signal detection

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs. The role involves cross-functional collaboration with development teams and partners to evaluate safety signals, review reports, and contribute to regulatory submissions.

Ideal candidates have at least 6 years in pharmacovigilance, strong leadership, and experience in oncology/neurology safety.