Remote Safety Scientist Manager, Pharmacovigilance

Sumitomo Pharma; Phoenix (AZ); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America is seeking a Safety Scientist Manager to lead pharmacovigilance and risk management across product lifecycles. You will guide signal detection, aggregate safety reporting, safety governance, and cross-functional collaboration to ensure patient safety and regulatory compliance.

The role emphasizes inspection readiness, collaboration with PV and medical safety, and external partnerships, with a primarily remote work setup and potential on-site meetings as needed.

Qualifications

• Minimum bachelor’s level degree in a health care/life science related field
• Minimum 4 years experience within Pharmacovigilance and in the pharmaceutical industry
• Experience in oncology and/or neurology preferred
• Strong knowledge of FDA/EMA/GCP/GVP guidelines and safety reporting requirements

Responsibilities

• Provide pharmacovigilance and risk management support across product lifecycles
• Lead signal detection, safety surveillance, and literature monitoring activities
• Coordinate aggregate safety reporting and ensure inspection readiness contributions
• Represent PV Operations in cross-functional teams and external collaborations
• Respond to regulatory inquiries and support safety governance activities
• Support ongoing process improvements and audit readiness

Skills

Pharmacovigilance

Signal detection

Aggregate reporting

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Master's degree preferred

Tools

Veeva

PV safety databases

Job description

Sumitomo Pharma America is seeking a Safety Scientist Manager to lead pharmacovigilance and risk management across product lifecycles. You will guide signal detection, aggregate safety reporting, safety governance, and cross-functional collaboration to ensure patient safety and regulatory compliance.

The role emphasizes inspection readiness, collaboration with PV and medical safety, and external partnerships, with a primarily remote work setup and potential on-site meetings as needed.