Remote Pharmacovigilance Safety Manager

Sumitomo Pharma; Lincoln (NE); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America (SMPA) seeks a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles, collaborating with PV, Medical Safety, and cross-functional stakeholders to ensure patient safety and regulatory compliance.

The role leads signal detection, aggregate safety reporting, safety governance, and inspection readiness, acting as a subject matter expert within assigned programs and coordinating with external partners as needed.

Qualifications

• Bachelor’s degree in health care or life sciences; Master’s preferred.
• Minimum 4 years of pharmacovigilance and pharmaceutical industry experience.
• Experience in oncology and/or neurology preferred; FDA/EU/GCP/GVP knowledge.

Responsibilities

• Manage benefit-risk profile and patient safety across the product lifecycle.
• Lead signal detection, data assembly, and literature monitoring.
• Lead aggregate safety reporting and write sections with vendor support.
• Coordinate safety issues responses with regulators and teams; inspection readiness.

Skills

Pharmacovigilance knowledge

Signal detection

Data analysis

Cross-functional collaboration

Regulatory knowledge (FDA/EMA/GVP)

Safety reporting

Communication

Education

Bachelor’s degree in health care/life sciences

Master’s degree preferred

Job description

Sumitomo Pharma America (SMPA) seeks a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles, collaborating with PV, Medical Safety, and cross-functional stakeholders to ensure patient safety and regulatory compliance.

The role leads signal detection, aggregate safety reporting, safety governance, and inspection readiness, acting as a subject matter expert within assigned programs and coordinating with external partners as needed.