Key Responsibilities:

Provide support to the Complaint Vigilance process within the Asia Pacific region through periodic monitoring of complaints. This may include but is not limited to, triage, investigation, trending, issues resolution. Provide periodic training and support to the triage and investigation team to ensure compliance with the complaint management process.

  • Reviews product quality complaints and processes in accordance with Standard Operating Procedures using the Complaints Management System. This may include, but is not limited to, review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable.
  • Analyzes data, prepare, and disseminate weekly complaints report to region.
  • Reviews and processes updated information for complaints received as changelogs from call center and medical safety to assess the impact on triage and investigation. This may include, but is not limited to, necessary actions such as timely notification to the impacted sites to process the same, communication with business partners to ensure compliance.
  • Collaborates with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process.
  • Assists with developing training presentations for complaint vigilance process and systems.
  • Assists with global and regional projects within the department, communicate effectively with all levels of management.

Qualification: B.Pharma/M.Pharma

Experience: Minimum 3 Years in Quality Systems and Compliance

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