Pharmacovigilance Training & SOPs Lead

ICON Strategic Solutions

United States

On-site

USD 85,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Annual leave
Health insurance
Retirement planning
LifeWorks EAP
Life assurance
Country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Pharmacovigilance Training Specialist to strengthen our sponsor-dedicated pharmacovigilance model. You will design, deliver, and maintain training on quality standards within PV, ensuring inspection readiness and alignment with CFR/GVP, ICH, and GCP.

You will collaborate with internal teams and external providers, manage training documentation, and support audits and inspections while promoting continuous improvement across the Pharmacovigilance function.

Qualifications

  • Experience preparing and delivering training to diverse audiences.
  • Familiarity with learning management systems; Veeva preferred.
  • Knowledge of CFR/GVP, ICH Guidelines and GCP in pharmacovigilance.
  • Bachelor’s degree in science or healthcare-related discipline or equivalent.

Responsibilities

  • Ensure compliance with internal procedures, regulatory requirements, and partner agreements.
  • Coordinate development, review and maintenance of PV quality standards documents.
  • Manage training documentation through approval lifecycle in systems.
  • Train PV staff and external service providers as requested.
  • Support cross-functional SOP training and GPRM initiatives.
  • Maintain training records and ensure inspection readiness.
  • Support PV audits and inspections as needed.
  • Review and provide feedback on PV documents and templates.
  • Collaborate with internal teams and external partners.

Skills

English proficiency
Written communication
Verbal communication
Organizational skills
Time management
Problem solving
Teamwork
MS Word
MS Excel
Outlook
PowerPoint
GVP CFR ICH GCP knowledge
Training delivery
LMS experience

Education

Science or healthcare degree

Tools

Veeva eLMS
Veeva eDMS
Document management systems

Job description

ICON Strategic Solutions is seeking a Pharmacovigilance Training Specialist to strengthen our sponsor-dedicated pharmacovigilance model. You will design, deliver, and maintain training on quality standards within PV, ensuring inspection readiness and alignment with CFR/GVP, ICH, and GCP.

You will collaborate with internal teams and external providers, manage training documentation, and support audits and inspections while promoting continuous improvement across the Pharmacovigilance function.

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