Remote Senior Pharmacovigilance Scientist, PVRM Lead

Sumitomo Pharma; Dover (DE); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a Senior Manager, Pharmacovigilance Scientist for a US-remote, full-time role.

You will lead safety governance, review AE reports, support risk management, and collaborate with cross-functional teams to ensure compliant safety oversight across programs. Minimum 6 years in pharmacovigilance or drug safety, bachelor’s degree in a life science, and experience with regulatory submissions are preferred.

Qualifications

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

Responsibilities

• Lead Safety Management Team (SMT) meetings and provide safety guidance for documents and reports.
• Contribute to signal detection, safety evaluation, and communication of safety information.
• Maintain ongoing monitoring of safety profiles for products and support benefit-risk evaluation.
• Collaborate with cross-functional teams and represent PVRM on safety meetings.
• Review adverse event reports and safety-related documents.
• Support preparation and review of safety summaries, protocols, and clinical study reports.
• Develop and maintain PVRM documents and SOPs.
• Promote compliance and patient safety across programs.

Skills

Pharmacovigilance

Signal detection

Safety data analysis

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in life sciences

Tools

Regulatory knowledge tools

Job description

Sumitomo Pharma America, Inc. is seeking a Senior Manager, Pharmacovigilance Scientist for a US-remote, full-time role.

You will lead safety governance, review AE reports, support risk management, and collaborate with cross-functional teams to ensure compliant safety oversight across programs. Minimum 6 years in pharmacovigilance or drug safety, bachelor’s degree in a life science, and experience with regulatory submissions are preferred.