Senior PVRM Safety Leader (Remote)

Sumitomo Pharma; Trenton (NJ); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America is seeking a Senior Pharmacovigilance Scientist to serve as a primary PVRM contact for assigned programs. You will lead safety governance, review adverse events, and contribute to risk management activities across both investigational and marketed products.

The role requires strong cross-functional collaboration, experience with safety submissions, and a proactive approach to benefit-risk assessment. Remote work with periodic on-site meetings and travel may be needed.

Qualifications

• Minimum 6 years of pharmacovigilance, drug safety, or related experience.
• Experience with global safety requirements (FDA/EMA) preferred.
• Strong written and verbal communication in a cross-functional environment.

Responsibilities

• Lead Safety Management Team meetings and guide safety documents.
• Support signal detection, monitoring, and safety data analyses.
• Review adverse events and safety data across studies and products.
• Coordinate with Clinical Development, Regulatory, and other functions.

Skills

Pharmacovigilance

Drug safety

Signal detection

Risk management

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

Sumitomo Pharma America is seeking a Senior Pharmacovigilance Scientist to serve as a primary PVRM contact for assigned programs. You will lead safety governance, review adverse events, and contribute to risk management activities across both investigational and marketed products.

The role requires strong cross-functional collaboration, experience with safety submissions, and a proactive approach to benefit-risk assessment. Remote work with periodic on-site meetings and travel may be needed.