Senior PVRM Safety Scientist — Remote

Sumitomo Pharma; Salt Lake City (UT); Remote; USD 157,000 - 196,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Sumitomo Pharma America, Inc. in the United States is seeking a Senior Manager, Pharmacovigilance Scientist to serve as a primary PVRM contact for assigned programs, leading safety evaluation and risk management activities.

You will chair SMT meetings, review adverse events, ensure safety governance, collaborate with clinical development, regulatory, and QA teams, and support regulatory submissions and risk mitigation strategies across global programs.

Qualifications

• Bachelor’s degree in a healthcare or life sciences field required.
• Minimum 6 years in pharmacovigilance/drug safety.
• Experience with FDA/EMA safety requirements.
• Experience leading cross-functional safety activities.

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; support benefit-risk evaluation.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions; represent PVRM on cross-functional teams.
• Review adverse event reports, including serious cases, to support interpretation and quality across safety assessments.
• Support preparation and review of safety documents and regulatory responses.

Skills

Pharmacovigilance

Drug safety

Signal detection

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree in healthcare, life sciences, or related field

6+ years pharmacovigilance or drug safety experience

Job description

Sumitomo Pharma America, Inc. in the United States is seeking a Senior Manager, Pharmacovigilance Scientist to serve as a primary PVRM contact for assigned programs, leading safety evaluation and risk management activities.

You will chair SMT meetings, review adverse events, ensure safety governance, collaborate with clinical development, regulatory, and QA teams, and support regulatory submissions and risk mitigation strategies across global programs.