Safety Scientist Manager, Pharmacovigilance (US Remote)

Sumitomo Pharma; Carson City (NV); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support for products across their lifecycle. This role collaborates with PV, Medical Safety, and cross-functional teams to manage benefit-risk, ensure patient safety, and support regulatory compliance.

The position covers signal detection, aggregate safety reporting, safety governance, and inspection readiness, serving as an expert within assigned programs and coordinating with external

Qualifications

• Strong working knowledge of pharmacovigilance across product lifecycle.
• Ability to investigate safety issues and contribute to risk mitigation.
• Understanding of FDA, EMA/EU, ICH, GVP guidelines and safety reporting.

Responsibilities

• Provide pharmacovigilance and risk management support for assigned products.
• Lead aggregate safety reporting activities and write sections with vendor support.
• Coordinate with PV, Medical Safety, and cross-functional teams on safety governance.
• Respond to regulatory inquiries and support inspection readiness.

Skills

Pharmacovigilance

Risk management

Signal detection

Aggregate reporting

Regulatory knowledge

Education

Bachelor’s degree

Master’s degree preferred

Job description

Sumitomo Pharma America is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support for products across their lifecycle. This role collaborates with PV, Medical Safety, and cross-functional teams to manage benefit-risk, ensure patient safety, and support regulatory compliance.

The position covers signal detection, aggregate safety reporting, safety governance, and inspection readiness, serving as an expert within assigned programs and coordinating with external