Remote Senior PVRM Safety Scientist Lead

Sumitomo Pharma; Austin (TX); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs. You will collaborate with global development teams and partners to ensure robust safety governance.

The role includes leading SMT meetings, guiding safety documents, reviewing adverse events, and contributing to regulatory submissions and risk-management strategies. Domestic travel and remote work are involved.

Qualifications

• Minimum of a bachelor’s degree in healthcare, life science, or related field.
• Minimum 6 years of pharmacovigilance, drug safety, or related pharma/biotech experience.
• Experience leading cross-functional activities and teams.
• Comprehensive knowledge of FDA/EMA pharmacovigilance requirements.
• Prior oncology and/or neurology exposure is preferred.

Responsibilities

• Lead Safety Management Team meetings and provide safety guidance for documents.
• Contribute to signal detection, monitoring, and safety data interpretation.
• Review adverse event reports and safety assessments for quality consistency.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics and Data Management.
• Support preparation of safety documents, such as ISS/SCS and regulatory responses.
• Develop and maintain SOPs, RMPs, and risk-management materials.

Skills

Pharmacovigilance

Drug safety

Signal detection

Cross-functional collaboration

Leadership

Communication

Education

Bachelor's degree in healthcare or life sciences

Advanced degree preferred

Job description

Sumitomo Pharma America is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs. You will collaborate with global development teams and partners to ensure robust safety governance.

The role includes leading SMT meetings, guiding safety documents, reviewing adverse events, and contributing to regulatory submissions and risk-management strategies. Domestic travel and remote work are involved.