Remote Safety Scientist Manager – Pharmacovigilance

Sumitomo Pharma; Boise (ID); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma America is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles, collaborating with PV, Medical Safety, and cross-functional teams to manage benefit-risk profiles and ensure patient safety.

The role involves signal detection, aggregate safety reporting, safety governance, and inspection readiness, with a focus on regulatory compliance and external partnerships.

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.
• Familiarity with FDA/EMA/ICh guidelines and safety reporting.
• Ability to interpret safety data and collaborate with medical safety and other stakeholders.
• Experience working in a matrix environment and coordinating with external partners.

Responsibilities

• Collaborate with PV and cross-functional teams to manage the benefit-risk profile and ensure patient safety.
• Lead aggregate safety reporting, data analysis, and writing assigned sections with vendor support.
• Coordinate safety communications with regulatory authorities, clinical sites, and healthcare professionals.
• Contribute to safety governance forums and cross-functional SMT meetings.
• Support inspection readiness activities and safety oversight across programs.

Skills

Pharmacovigilance

Risk management

Signal detection

Literature monitoring

Safety governance

Cross-functional collaboration

Regulatory awareness

Communication skills

Inspection readiness

Data interpretation

Education

Bachelor's degree in life sciences

Master's degree preferred

Tools

Vendor management

Job description

Sumitomo Pharma America is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles, collaborating with PV, Medical Safety, and cross-functional teams to manage benefit-risk profiles and ensure patient safety.

The role involves signal detection, aggregate safety reporting, safety governance, and inspection readiness, with a focus on regulatory compliance and external partnerships.