Senior PVRM Pharmacovigilance Scientist - Remote

Sumitomo Pharma; Topeka (KS); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma is seeking a Senior Manager, Pharmacovigilance Scientist to lead PVRM activities for assigned programs. This role collaborates with cross-functional teams to ensure safety governance and robust benefit-risk assessments across investigational and marketed products.

The candidate will review safety data, drive signal detection, and contribute to regulatory submissions while mentoring junior staff.

Qualifications

• Bachelor’s degree in healthcare, life science, or related field.
• Minimum 6 years of pharmacovigilance, drug safety, or related industry experience.
• Experience with aggregate reporting and regulatory submissions preferred.

Responsibilities

• Lead Safety Management Team meetings and provide safety guidance for documents.
• Contribute to signal detection, evaluation, and safety data analysis.
• Review adverse event reports and safety data for consistency and quality.
• Coordinate safety issues with regulatory authorities and cross-functional teams.
• Develop and maintain PVRM SOPs and risk-management documents.
• Support preparation of regulatory submissions and responses.

Skills

Pharmacovigilance

Signal detection

Safety data analysis

Regulatory submissions

Cross-functional leadership

Communication

Education

Bachelor’s degree in healthcare / life sciences

Job description

Sumitomo Pharma is seeking a Senior Manager, Pharmacovigilance Scientist to lead PVRM activities for assigned programs. This role collaborates with cross-functional teams to ensure safety governance and robust benefit-risk assessments across investigational and marketed products.

The candidate will review safety data, drive signal detection, and contribute to regulatory submissions while mentoring junior staff.