Remote Senior Pharmacovigilance Safety Lead

Sumitomo Pharma; Honolulu (HI); Remote; USD 157,000 - 196,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Paid time off & holidays

Remote work

Job summary

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs and collaborate with global teams. The role focuses on safety evaluation, risk management, and regulatory responsiveness to ensure patient safety across compounds.

The candidate will guide SMT activities, oversee signal detection and safety analyses, and contribute to safety documentation and risk‑mitigation strategies within a fast-paced, remote setting.

Qualifications

• Bachelor's degree in healthcare, life science, or related field (advanced degree preferred).
• Minimum 6 years of pharmacovigilance/drug safety experience.
• Experience with safety data analysis and regulatory submissions.

Responsibilities

• Lead Safety Management Team (SMT) meetings and provide safety input for key documents.
• Oversee signal detection, monitoring, and safety data interpretation.
• Maintain ongoing safety profile assessments for products and support benefit–risk evaluation.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and Data Management.
• Review adverse event reports and support aggregate safety analyses.
• Coordinate safety issue escalations with regulatory authorities and cross‑functional teams.
• Develop and maintain PVRM documents and SOPs.

Skills

Pharmacovigilance

Signal detection

Regulatory submissions

Cross-functional collaboration

Leadership

Education

Bachelor's degree in life sciences

Job description

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs and collaborate with global teams. The role focuses on safety evaluation, risk management, and regulatory responsiveness to ensure patient safety across compounds.

The candidate will guide SMT activities, oversee signal detection and safety analyses, and contribute to safety documentation and risk‑mitigation strategies within a fast-paced, remote setting.