Remote Senior PVRM Safety Lead

Sumitomo Pharma; Atlanta (GA); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America is seeking a Senior Manager, Pharmacovigilance Scientist to lead and support safety evaluation and risk management for assigned programs. This role collaborates with global development teams and strategic partners to ensure compliant safety governance and robust risk management.

The position requires leading SMT meetings, overseeing safety documents, and contributing to safety signals, benefit-risk assessments, and regulatory interactions.

Qualifications

• Bachelor's degree in healthcare, life science, or related field.
• Minimum 6 years of pharmacovigilance or drug safety experience.
• Experience with regulatory submissions, safety reporting, and cross-functional collaboration.

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance on documents (IBs, ICFs, protocols).
• Contribute to signal detection, safety data evaluation, and communication of safety information.
• Monitor safety profiles of investigational and marketed products and support benefit-risk assessments.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions.

Skills

Pharmacovigilance

Signal detection

Safety data analysis

Regulatory submissions

Education

Bachelor's degree in healthcare or life science

Job description

Sumitomo Pharma America is seeking a Senior Manager, Pharmacovigilance Scientist to lead and support safety evaluation and risk management for assigned programs. This role collaborates with global development teams and strategic partners to ensure compliant safety governance and robust risk management.

The position requires leading SMT meetings, overseeing safety documents, and contributing to safety signals, benefit-risk assessments, and regulatory interactions.