Senior PVRM Safety Lead (Remote)

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

Job summary

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to serve as the primary PVRM contact for assigned programs. You will lead safety evaluation, governance processes, and risk management activities across clinical and regulatory teams.

The role requires strong PV expertise, ability to lead cross-functional teams, and experience with regulatory submissions and safety summaries.

Qualifications

• Bachelor’s degree in healthcare, life sciences or related field required.
• Minimum 6 years of pharmacovigilance, drug safety, or related pharma/biotech experience.
• Experience with safety governance, aggregate reporting, and regulatory interactions preferred.

Responsibilities

• Lead SMT meetings and provide safety guidance for documents and regulatory responses.
• Monitor safety profiles and support benefit-risk evaluations for products.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and others on safety matters.
• Review adverse event reports and support safety signal detection and aggregate analyses.
• Develop and maintain PVRM safety documents and SOPs.

Skills

Pharmacovigilance

Signal detection

Safety data analysis

Cross-functional leadership

Regulatory submissions

Risk management

Education

Bachelor's degree in healthcare or life sciences

Advanced degree preferred

Job description

Sumitomo Pharma America (SMPA) is seeking a Senior Manager, Pharmacovigilance Scientist to serve as the primary PVRM contact for assigned programs. You will lead safety evaluation, governance processes, and risk management activities across clinical and regulatory teams.

The role requires strong PV expertise, ability to lead cross-functional teams, and experience with regulatory submissions and safety summaries.