Remote PV Safety Manager — Signal & Risk Lead

Sumitomo Pharma; Helena (MT); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America seeks a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles. You will collaborate with PV, Medical Safety, and cross-functional partners to manage benefit-risk profiles, ensure patient safety, and support regulatory compliance.

You will contribute to signal detection, aggregate safety reporting, safety governance forums, and inspection readiness activities, acting as a subject matter expert within assigned programs.

Qualifications

• Strong working knowledge of pharmacovigilance and risk management principles across the product lifecycle.
• Ability to investigate, assess, and resolve safety-related issues, including signal evaluation and risk mitigation.
• Solid understanding of FDA, EMA/EU, ICH, GVP and local regulations; experience preparing safety reports and regulatory responses.

Responsibilities

• Collaborate with PV and cross-functional teams to manage the benefit-risk profile of assigned products and ensure patient safety.
• Assist in signal detection activities, including data assembly, signal validation, and signal evaluation.
• Lead aggregate safety reporting activities, including data compilation, analysis, and writing of sections with vendor support as applicable.
• Prepare agendas, data, materials, and meeting minutes for cross-functional Safety Management Team meetings.
• Coordinate responses to ad hoc safety issues and regulatory inquiries in collaboration with PV physicians.
• Contribute to inspection readiness activities and continuous process improvements within PVRM and across functions.
• Serve as a subject matter expert in pharmacovigilance for assigned programs and support external partnerships as needed.
• Maintain awareness of safety data from literature and other sources to inform safety surveillance.

Skills

Pharmacovigilance

Signal detection

Data analysis

Regulatory compliance

Cross-functional collaboration

Safety governance

Education

Bachelor's degree in health care/life sciences

Master's degree preferred

Job description

Sumitomo Pharma America seeks a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles. You will collaborate with PV, Medical Safety, and cross-functional partners to manage benefit-risk profiles, ensure patient safety, and support regulatory compliance.

You will contribute to signal detection, aggregate safety reporting, safety governance forums, and inspection readiness activities, acting as a subject matter expert within assigned programs.