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Pharmacovigilance Training Associate

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4-8 years
Not Disclosed
Remote, USA, Remote
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Pharmacovigilance Training Associate

Location: Blue Bell, Pennsylvania, United States
Work Mode: Remote
Job Type: Full-Time
Experience Required: Minimum 4–8+ Years in Pharmacovigilance, Drug Safety, SOP Management, or PV Training
Industry: Pharmaceutical / Clinical Research / CRO


Job Overview

We are seeking a highly organized and detail-oriented Pharmacovigilance Training Associate to support pharmacovigilance quality systems, SOP management, and training operations within a global drug safety environment. The selected candidate will play a key role in maintaining inspection readiness, managing pharmacovigilance training records, supporting quality documentation, and ensuring compliance with global regulatory standards.

This role is ideal for professionals with expertise in pharmacovigilance operations, SOP lifecycle management, training coordination, regulatory compliance, and quality systems within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

Pharmacovigilance SOP & Quality Documentation Management

  • Coordinate development, review, maintenance, and lifecycle management of:
    • Pharmacovigilance SOPs
    • Quality standards documents
    • Regulatory documentation
    • Safety process templates
  • Support document approvals and updates within document management systems.
  • Ensure all documentation remains:
    • Accurate
    • Current
    • Compliant
    • Inspection-ready.

Pharmacovigilance Training Management

  • Support development and maintenance of:
    • Pharmacovigilance training programs
    • Safety training initiatives
    • Cross-functional SOP training activities
  • Train:
    • Pharmacovigilance staff
    • Vendors
    • External service providers
  • Maintain accurate and up-to-date training records for audit and inspection readiness.

Regulatory Compliance & Inspection Readiness

  • Ensure compliance with:
    • Global pharmacovigilance regulations
    • Internal procedures
    • Partner agreements
    • Quality standards
  • Support:
    • Regulatory inspections
    • Internal audits
    • Quality reviews
    • Compliance monitoring
  • Assist in maintaining Pharmacovigilance System Master File documentation where applicable.

Cross-Functional Collaboration

  • Collaborate with:
    • Pharmacovigilance leadership
    • Quality Assurance teams
    • Clinical Operations
    • External service providers
    • Cross-functional stakeholders
  • Support identification of SOPs requiring training and process alignment.
  • Provide technical expertise on pharmacovigilance quality and training processes.

Quality Improvement & Operational Support

  • Identify quality or compliance issues and recommend corrective actions.
  • Review pharmacovigilance documents and provide feedback to improve consistency and compliance.
  • Support continuous improvement initiatives for:
    • Training systems
    • SOP management
    • Quality workflows
    • Compliance operations.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree in:
    • Pharmacy
    • Life Sciences
    • Biotechnology
    • Nursing
    • Healthcare
    • Or related scientific disciplines

Preferred Qualification

  • Advanced Degree or certifications in:
    • Pharmacovigilance
    • Drug Safety
    • Regulatory Affairs
    • Clinical Research
    • Quality Management