Remote Pharmacovigilance Safety Manager

Sumitomo Pharma; Topeka (KS); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking a Safety Scientist Manager for a primarily remote, full‑time role. You will drive pharmacovigilance across product lifecycles, ensure patient safety, and support regulatory compliance in collaboration with PV, Medical Safety, and cross‑functional teams.

You will lead signal detection, aggregate safety reporting, safety governance activities, and inspection readiness while serving as a subject matter expert for assigned programs.

Qualifications

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

Responsibilities

• Collaborate with PV and cross-functional teams to manage benefit-risk profiles and patient safety
• Lead signal detection activities, data assembly, validation, and evaluation
• Contribute to literature monitoring and incorporation into safety surveillance
• Lead aggregate safety report activities, data analysis and writing sections
• Represent PV Operations in cross-functional program teams and support safety activities
• Coordinate responses to regulatory inquiries and maintain inspection readiness
• Support safety governance activities and continuous process improvements

Skills

Pharmacovigilance

Benefit-risk assessment

Signal detection

Data analysis

Literature monitoring

Regulatory knowledge

Collaboration

Communication

Education

Bachelor's in health care/life sciences

Master’s degree preferred

Job description

Sumitomo Pharma America (SMPA) is seeking a Safety Scientist Manager for a primarily remote, full‑time role. You will drive pharmacovigilance across product lifecycles, ensure patient safety, and support regulatory compliance in collaboration with PV, Medical Safety, and cross‑functional teams.

You will lead signal detection, aggregate safety reporting, safety governance activities, and inspection readiness while serving as a subject matter expert for assigned programs.