Senior Safety Scientist, Pharmacovigilance (Remote)

Sumitomo Pharma; Trenton (NJ); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America is seeking a Safety Scientist Manager to oversee pharmacovigilance and risk management activities across product lifecycles. The role collaborates with PV, Medical Safety, and cross-functional teams to ensure patient safety and regulatory compliance.

The position emphasizes signal detection, aggregate safety reporting, and safety governance, with remote work predominance and periodic on-site meetings. Domestic/international travel may be required.

Qualifications

• Bachelor’s degree in a health care/life science related field.
• Master’s or other graduate degree preferred.
• Minimum 4 years experience within Pharmacovigilance.
• Experience in oncology and/or neurology strongly preferred.
• Comprehensive understanding of FDA/EU legislation and GCP/GVP/ICH safety guidelines.

Responsibilities

• Manage benefit-risk and safety surveillance across product lifecycle.
• Lead aggregate safety reporting with data analysis and writing.
• Support safety governance and cross-functional Safety Management Team meetings.
• Coordinate regulatory safety inquiries and responses with PV physicians.
• Support inspection readiness and process improvements within PVRM and across functions.

Skills

Pharmacovigilance

Regulatory knowledge

Signal detection

Cross-functional teamwork

Communication

Education

Bachelor's degree in health care/life sciences

Master's degree preferred

Job description

Sumitomo Pharma America is seeking a Safety Scientist Manager to oversee pharmacovigilance and risk management activities across product lifecycles. The role collaborates with PV, Medical Safety, and cross-functional teams to ensure patient safety and regulatory compliance.

The position emphasizes signal detection, aggregate safety reporting, and safety governance, with remote work predominance and periodic on-site meetings. Domestic/international travel may be required.