Remote Safety Scientist Manager, Pharmacovigilance

Sumitomo Pharma; Madison (WI); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across the product lifecycle. You will work with PV, Medical Safety, and cross‑functional teams to manage safety signals and prepare regulatory safety documents.

Responsibilities include signal detection, aggregate reporting, safety governance, and inspection readiness. Requires strong PV knowledge, 4+ years in pharma, and familiarity with FDA/EMA guidelines.

Qualifications

• Strong working knowledge of pharmacovigilance and risk management across product lifecycle.
• Ability to investigate and resolve safety issues, contribute to signal evaluation and risk mitigation.
• Understanding of FDA/EMA/GCP/GVP guidance and regulatory safety reporting.

Responsibilities

• Lead benefit-risk assessment and safety surveillance for assigned products.
• Coordinate aggregate safety reporting with data analysis and writing responsibilities.
• Represent PV operations in cross-functional program and project teams.
• Coordinate responses to regulatory inquiries and safety data requests.
• Support inspection readiness activities and safety governance processes.
• Collaborate with external partners and vendors on safety oversight.

Skills

Pharmacovigilance

Signal detection

Safety reporting

FDA/ICH/GVP knowledge

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in health/life sciences

Master's degree preferred

Job description

Sumitomo Pharma Co., Ltd. is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across the product lifecycle. You will work with PV, Medical Safety, and cross‑functional teams to manage safety signals and prepare regulatory safety documents.

Responsibilities include signal detection, aggregate reporting, safety governance, and inspection readiness. Requires strong PV knowledge, 4+ years in pharma, and familiarity with FDA/EMA guidelines.