Remote Safety Scientist Manager

Sumitomo Pharma; Honolulu (HI); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles. You will work with PV, Medical Safety, and cross-functional teams to maintain benefit-risk profiles, ensure patient safety, and support regulatory compliance.

The role covers signal detection, aggregate safety reporting, safety governance, and inspection readiness, serving as a subject matter expert within assigned programs.

Qualifications

• Bachelor's degree in health care or life sciences.
• Master's degree preferred.
• Minimum 4 years in Pharmacovigilance.
• Experince in oncology or neurology preferred.
• Knowledge of FDA/EMA/GVP/ICH safety guidelines.

Responsibilities

• Collaborate with PV and cross-functional teams to manage product safety.
• Assist in signal detection, data assembly, validation, and evaluation.
• Lead aggregate safety reporting activities with data analysis and writing sections.
• Prepare safety governance materials and support SMT meetings.
• Coordinate responses to safety issues with regulators and stakeholders.

Skills

Pharmacovigilance

Signal detection

Regulatory compliance

Cross-functional collaboration

Safety reporting

Education

Bachelor's degree in health sciences

Master's degree preferred

Job description

Sumitomo Pharma America (SMPA) is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles. You will work with PV, Medical Safety, and cross-functional teams to maintain benefit-risk profiles, ensure patient safety, and support regulatory compliance.

The role covers signal detection, aggregate safety reporting, safety governance, and inspection readiness, serving as a subject matter expert within assigned programs.