Remote Senior PVRM Safety Scientist Lead

Sumitomo Pharma; Helena (MT); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America is seeking a Senior Pharmacovigilance Scientist to serve as a primary PVRM contact for assigned programs, leading safety evaluation and risk management activities. You will ensure governance processes are applied to safety across compounds and products.

You will collaborate with global teams, review adverse event reports, contribute to signal detection, and support regulatory submissions with a focus on patient safety and compliant pharmacovigilance operations.

Qualifications

• Minimum of a bachelor’s degree in a healthcare, life science, or related scientific field.
• Minimum 6 years of relevant pharmacovigilance, drug safety, or related pharmaceutical/biotechnology industry experience.
• Comprehensive understanding of FDA/EU pharmacovigilance requirements and GCP/GVP/ICH safety guidelines for investigational and marketed products.

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance for key documents.
• Contribute to signal detection, evaluation, and safety data analysis.
• Maintain ongoing monitoring of safety profiles for assigned products and supporting benefit-risk evaluation.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions.

Skills

Pharmacovigilance

Drug safety

Signal detection

Safety data analysis

Cross-functional collaboration

Leadership

Education

Bachelor's degree in healthcare or life science

Job description

Sumitomo Pharma America is seeking a Senior Pharmacovigilance Scientist to serve as a primary PVRM contact for assigned programs, leading safety evaluation and risk management activities. You will ensure governance processes are applied to safety across compounds and products.

You will collaborate with global teams, review adverse event reports, contribute to signal detection, and support regulatory submissions with a focus on patient safety and compliant pharmacovigilance operations.