Senior PVRM Safety Scientist — Remote

Sumitomo Pharma; United States; Remote; USD 157,000 - 196,000; Full time

Benefits offered by this job

Merit-based salary increases

401(k) plan

Medical, dental, vision insurance

Flexible paid time off and holidays

Job summary

Sumitomo Pharma America (SMPA) is seeking a Senior Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs. The role collaborates with global development teams and strategic partners to ensure safety governance and timely regulatory responses.

The successful candidate will oversee SMT meetings, signal detection, and safety data analyses, while guiding cross-functional teams across Clinical Development, Regulatory, Biostatistics, and Data Management.

Qualifications

• Bachelor's degree in healthcare, life sciences, or related field; advanced degree preferred.
• Minimum of 6 years of pharmacovigilance or drug safety experience.
• Experience in oncology and/or neurology is preferred.
• Knowledge of FDA/EU pharmacovigilance requirements and GCP/GVP/ICH guidelines.

Responsibilities

• Lead cross-functional Safety Management Team meetings and provide safety input to documents.
• Review adverse event reports and support safety assessments.
• Collaborate with Clinical Development, Regulatory, Biostatistics, Data Management.
• Support preparation of safety submissions and regulatory responses.
• Develop and maintain PVRM documents and SOPs.
• Participate in aggregate safety report activities and safety reviews.

Skills

Pharmacovigilance experience

Signal management

Safety data analysis

Regulatory submissions familiarity

Project leadership

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in healthcare, life sciences, or related field

Job description

Sumitomo Pharma America (SMPA) is seeking a Senior Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs. The role collaborates with global development teams and strategic partners to ensure safety governance and timely regulatory responses.

The successful candidate will oversee SMT meetings, signal detection, and safety data analyses, while guiding cross-functional teams across Clinical Development, Regulatory, Biostatistics, and Data Management.