Remote PV Safety Scientist Manager

Sumitomo Pharma; Olympia (WA); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma is seeking a Safety Scientist Manager to lead pharmacovigilance and risk management across products. You will work with PV, Medical Safety, and cross-functional partners to ensure patient safety and regulatory compliance.

You will contribute to signal detection, aggregate safety reporting, and safety governance forums, while serving as a subject matter expert. The role emphasizes inspection readiness and external collaborations with vendors and partners.

Qualifications

• Strong pharmacovigilance and risk-management knowledge across product lifecycles.
• Experience investigating safety issues and contributing to signal evaluation and risk mitigation.
• Familiarity with FDA/EMA/GVP/ICH guidelines and safety reporting requirements.

Responsibilities

• Lead pharmacovigilance activities and ensure safety governance for programs.
• Coordinate signal detection, data analysis, and safety reporting with vendors as needed.
• Prepare inspection-ready safety documentation and regulatory responses.
• Collaborate with PV Ops, Medical Safety, and cross-functional teams.
• Support regulatory interactions and responses to safety inquiries.
• Contribute to safety risk management and continuous process improvements.

Skills

Pharmacovigilance

Signal detection

Safety surveillance

Regulatory knowledge

Cross-functional collaboration

Inspection readiness

Education

Bachelor’s degree in health sciences

Master’s degree preferred

Tools

Safety databases

Regulatory submissions tools

Job description

Sumitomo Pharma is seeking a Safety Scientist Manager to lead pharmacovigilance and risk management across products. You will work with PV, Medical Safety, and cross-functional partners to ensure patient safety and regulatory compliance.

You will contribute to signal detection, aggregate safety reporting, and safety governance forums, while serving as a subject matter expert. The role emphasizes inspection readiness and external collaborations with vendors and partners.