Remote Senior PVRM Safety Scientist Lead

Sumitomo Pharma; Denver (CO); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America (SMPA) seeks a Senior Manager, Pharmacovigilance Scientist to lead safety governance, SMT activities, and cross-functional risk management for assigned programs. You will drive signal detection, safety reviews, and collaboration with Clinical Development, Regulatory, and other functions in a global context.

The role requires strong leadership, advanced knowledge of FDA/EU PV requirements, and the ability to deliver high-quality safety documentation and responses to

Qualifications

• Strong pharmacovigilance knowledge and global safety requirements.
• Experience with signal management and safety data analyses.
• Ability to communicate safety findings to cross-functional teams.

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance to key documents.
• Contribute to signal detection, evaluation, and risk communication.
• Maintain ongoing safety monitoring for assigned products and contribute to benefit-risk reviews.
• Collaborate with Clinical Development, Regulatory, Biostatistics and Data Management.

Skills

Pharmacovigilance

Signal detection

Safety data analysis

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in Life Sciences

Job description

Sumitomo Pharma America (SMPA) seeks a Senior Manager, Pharmacovigilance Scientist to lead safety governance, SMT activities, and cross-functional risk management for assigned programs. You will drive signal detection, safety reviews, and collaboration with Clinical Development, Regulatory, and other functions in a global context.

The role requires strong leadership, advanced knowledge of FDA/EU PV requirements, and the ability to deliver high-quality safety documentation and responses to