Remote Senior PVRM Safety Scientist Lead

Sumitomo Pharma; Annapolis (MD); Remote; USD 157,000 - 196,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Flexible PTO

Holidays

Sick time

Job summary

Sumitomo Pharma America (SMPA) seeks a Senior Manager, Pharmacovigilance Scientist to lead safety and risk management for assigned programs. You will guide SMTs, oversee safety governance, and collaborate with development teams to ensure high-quality safety evaluations.

You will review adverse events, support regulatory submissions, and contribute to risk-mitigation strategies in a global landscape with oncology and neurology focus. Remote with on-site travel optional.

Qualifications

• Minimum of a bachelor’s degree in a healthcare, life science, or related field.
• Minimum 6 years in pharmacovigilance, drug safety, or related industry.
• Experience with clinical safety, signal management, and aggregate reporting preferred.
• Leadership of cross-functional activities is strongly preferred.
• Oncology and/or neurology experience is a plus.
• Knowledge of FDA and EU pharmacovigilance requirements and ICH guidelines.

Responsibilities

• Lead SMT meetings and provide safety guidance for core documents.
• Contribute to signal detection, evaluation, and safety data analysis.
• Review adverse event reports to ensure quality and consistency.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and Data Management.
• Lead cross-functional teams and participate in joint safety forums.
• Prepare safety submissions and responses to regulatory authorities.
• Develop risk-mitigation strategies and safety documents.

Skills

Pharmacovigilance

Drug safety

Signal management

Cross-functional collaboration

Regulatory submissions

Written communication

Education

Bachelor’s degree in healthcare or life sciences

Advanced degree preferred

Job description

Sumitomo Pharma America (SMPA) seeks a Senior Manager, Pharmacovigilance Scientist to lead safety and risk management for assigned programs. You will guide SMTs, oversee safety governance, and collaborate with development teams to ensure high-quality safety evaluations.

You will review adverse events, support regulatory submissions, and contribute to risk-mitigation strategies in a global landscape with oncology and neurology focus. Remote with on-site travel optional.