Senior Pharmacovigilance Manager

Sumitomo Pharma

United States

Remote

USD 128,000 - 160,000

Full time

10 days ago
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Job summary

Sumitomo Pharma America 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 partners to manage benefit‑risk, ensure patient safety, and support regulatory compliance.

Responsibilities include signal detection, aggregate safety reporting, safety governance, and inspection readiness, with external partnerships as applicable.

Qualifications

  • Bachelor’s degree in health care or life sciences required.
  • Minimum 4 years of pharmacovigilance experience in pharma.
  • Oncology and/or neurology experience preferred.
  • Solid knowledge of FDA, EU/GVP, ICH guidance.

Responsibilities

  • Provide PV and risk management support across product lifecycles.
  • Lead signal detection, data assembly, and safety evaluation.
  • Prepare and review safety reports and regulatory responses.
  • Support inspection readiness and safety governance activities.
  • Collaborate with cross-functional teams and external partners.

Skills

Pharmacovigilance knowledge
Analytical thinking
Communication skills
Team collaboration
Independent work

Education

Bachelor's in health sciences
Master's degree preferred

Job description

Sumitomo Pharma America 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 partners to manage benefit‑risk, ensure patient safety, and support regulatory compliance.

Responsibilities include signal detection, aggregate safety reporting, safety governance, and inspection readiness, with external partnerships as applicable.

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