Remote Senior PVRM Safety Scientist Lead

Sumitomo Pharma

Boise (ID)

Remote

USD 157,000 - 196,000

Full time

9 days ago

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Job summary

Sumitomo Pharma America seeks a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs, collaborating with global development teams to ensure rigorous PV activities and proactive risk management. You will chair SMT meetings, guide signal detection and adverse event reviews, and contribute to safety documents (IBs, CSR summaries, regulatory responses).

A bachelor’s degree in life sciences and at least six years in pharmacovigilance are required;

Qualifications

  • Bachelor's degree in life sciences or related field.
  • Minimum 6 years of pharmacovigilance or drug safety experience.
  • Experience with oncology/neurology PV preferred.
  • Strong cross-functional collaboration and communication skills.

Responsibilities

  • Lead Safety Management Team (SMT) meetings and provide safety guidance to key documents (IBs, ICFs, protocols, study reports, regulatory responses).
  • Review adverse events and support safety submissions and regulatory responses, including signal detection and safety data analyses.

Skills

Pharmacovigilance
Signal detection
Cross‑functional collaboration
Leadership
Regulatory submissions

Education

Bachelor's degree in life sciences
6+ years pharmacovigilance experience

Job description

Sumitomo Pharma America seeks a Senior Manager, Pharmacovigilance Scientist to lead safety governance for assigned programs, collaborating with global development teams to ensure rigorous PV activities and proactive risk management. You will chair SMT meetings, guide signal detection and adverse event reviews, and contribute to safety documents (IBs, CSR summaries, regulatory responses).

A bachelor’s degree in life sciences and at least six years in pharmacovigilance are required;

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