Senior Safety Scientist Manager - Pharmacovigilance (Remote)

Sumitomo Pharma; Austin (TX); Remote; USD 128,000 - 160,000; Full time

Job summary

Sumitomo Pharma is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles. You will collaborate with PV, Medical Safety, and cross‑functional teams to manage benefit‑risk, signal detection, and safety governance.

You will participate in aggregate safety reporting, inspections, and regulatory interactions, contributing to safety governance forums and SMT meetings.

Qualifications

• Bachelor’s degree in health care or life sciences.
• Minimum 4 years in pharmacovigilance within the pharmaceutical industry.
• Experience with oncology or neurology preferred.
• Knowledge of FDA, EMA, ICH, and GVP guidelines.

Responsibilities

• Collaborate with PV and cross-functional teams to manage benefit‑risk profiles and patient safety.
• Lead aggregate safety reporting activities, data analysis, and writing of sections with vendor support.
• Prepare agendas and materials for cross‑functional Safety Management Team meetings.
• Coordinate responses to regulatory inquiries and safety data requests with PV physicians.
• Support inspection readiness activities and continuous process improvements in PVRM and related functions.

Skills

Pharmacovigilance

Regulatory knowledge

Cross-functional collaboration

Scientific writing

Education

Bachelor's degree in health care or life sciences

Master's or graduate degree preferred

Job description

Sumitomo Pharma is seeking a Safety Scientist Manager to provide pharmacovigilance and risk management support across product lifecycles. You will collaborate with PV, Medical Safety, and cross‑functional teams to manage benefit‑risk, signal detection, and safety governance.

You will participate in aggregate safety reporting, inspections, and regulatory interactions, contributing to safety governance forums and SMT meetings.