Sr. Specialist Drug Safety - Qppv Governance

Organon

Not specified
Pharmacovigilance regulations
Gvp module ii
Psmf management
Organon is seeking a Sr. Specialist in Drug Safety focused on QPPV Governance to enhance its pharmacovigilance processes and documentation management. The role involves overseeing procedural documentation, maintaining the Pharmacovigilance System Master File (PSMF), and managing training related to adverse event reporting

Job Summary

  • The Sr. Specialist, Drug Safety – QPPV Governance will support the management and quality of procedural documentation wherein procedures are updated and quality by design is incorporated into the SOP update process.
  • This role will also support the maintenance of the Pharmacovigilance System Master File (PSMF) which will support product registration, renewal and provide an overview of Organon’s PV System.
  • The Sr. PV Specialist will also maintain a robust PV Training system along with the Adverse Event reporting training course.

Matching Summary

Match Score: 85

Organon is seeking a Sr. Specialist in Drug Safety focused on QPPV Governance to enhance its pharmacovigilance processes and documentation management. The role involves overseeing procedural documentation, maintaining the Pharmacovigilance System Master File (PSMF), and managing training related to adverse event reporting.

Skills & Requirements

Must-have

  • Pharmacovigilance regulations
  • GVP Module II
  • PSMF management
  • PV training system
  • Adverse Event reporting

Nice-to-have

  • Quality by design
  • Cross-functional collaboration
  • Continuous improvement
  • Inspection readiness

Key Requirements

  • Bachelor’s degree in life science/health care/pharmaceutical related field
  • Previous Experience in Pharmacovigilance / ICSR Processing / Regulatory Affairs required
  • Fluent in written and spoken English

Work Rights

Not specified

Tailored Resume

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