Pharmacovigilance Qa Emea Auditor

Johnson & Johnson Johnson & Johnson · Pharma · Milano, Italy +5

Johnson & Johnson is seeking a Pharmacovigilance QA Auditor Specialist to lead the planning, conduct, and reporting of pharmacovigilance audits, support non-routine audits, and assist with regulatory inspections. The role involves project management, providing consultation to business partners, and ensuring compliance within a GVP-regulated environment.

What you'd actually do

  1. Leads the planning, conduct and reporting of Pharmacovigilance routine audits
  2. Supports non-routine Pharmacovigilance audits of activities, data, internal facilities and processes in GxP areas
  3. Participates in projects or serves on teams, as assigned by supervisor.
  4. Supports regulatory inspections in various supporting roles.
  5. Provides consultation to business partners on routine tasks with occasional supervision.

Skills

Required

  • Bachelor’s or equivalent University degree required; Focused degree in natural/biological sciences or equivalent
  • Strong verbal and written communication skills, including presentation skills
  • Strong teamwork and analytical skills
  • Ability to work effectively as part of a collaborative team
  • Fluency in English

Nice to have

  • Agile Internal Audit
  • Analytical Reasoning
  • Audit and Compliance Trends
  • Audit Reporting
  • Business Behavior
  • Compliance Management
  • Compliance Policies
  • Compliance Risk
  • Critical Thinking
  • Detail-Oriented
  • Problem Solving
  • Quality Control (QC)
  • Quality Standards
  • Regulatory Environment
  • Minimum of 2 years’ experience in a GVP-regulated environment is preferred, with demonstrated exposure to Pharmacovigilance activities.

What the JD emphasized

  • GxP areas
  • Pharmacovigilance activities