Job Description

  • Receives, inputs, and processes vigilance reports/ adverse events reports in Vigilance System

  • Point Person for submission of HPV documents to local health authority

  • Submits Risk Management Plan, PSUR/PBRER, FSCA and Safety communication

  • Creates Health product RMP local annexure

  • Complies with local Health Product Vigilance (HPV) regulations

  • Reviews Health Vigilance Agreements or any equivalent agreements

  • Conducts HPV awareness training, refresher training, and re-training for alli.e. HPV team members, Healthcare employees, third party service provider under DKSH MES Healthcare)

  • Conducts onboard HPV awareness training for DKSH MES new hires

  • Point person for CAPA related to HPV process

  • Ensures mock reporting is conducted for system tests of VR process

  • Ensures Vigilance System validation

  • Point Person for HPV Audits

  • Ensures that Deputy QPPV unde...

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