Safety Scientist Manager (PV) – Remote

Sumitomo Pharma; Santa Fe (NM); Teletrabalho; USD 128 000 - 160 000; Tempo integral

Resumo da oferta

Sumitomo Pharma America is seeking a Safety Scientist Manager to lead pharmacovigilance and risk management activities for assigned products across their lifecycle. You will collaborate with PV, Medical Safety, and cross‑functional teams to ensure patient safety, manage signal detection, and contribute to inspection readiness.

The role emphasizes high‑quality safety reporting, governance participation, and external partner coordination.

Qualificações

• Pharmacovigilance knowledge across product lifecycle
• Ability to investigate and resolve safety issues, contribute to signal evaluation
• Understanding of FDA, EU, ICH, GVP guidelines and regulatory safety reporting

Responsabilidades

• Support benefit‑risk management and patient safety across product lifecycle
• Lead and contribute to aggregate safety reporting and safety governance activities
• Coordinate regulatory interactions and responses with PV physicians and cross‑functional partners
• Support inspection readiness activities and process improvements within PV operations

Conhecimentos

Pharmacovigilance

Safety signal detection

Regulatory compliance

Cross-functional collaboration

Medical writing

Inspection readiness

Formação académica

Bachelor’s degree in life sciences

Master’s degree preferred

Descrição da oferta de emprego

Sumitomo Pharma America is seeking a Safety Scientist Manager to lead pharmacovigilance and risk management activities for assigned products across their lifecycle. You will collaborate with PV, Medical Safety, and cross‑functional teams to ensure patient safety, manage signal detection, and contribute to inspection readiness.

The role emphasizes high‑quality safety reporting, governance participation, and external partner coordination.