Post Market Surveillance and Risk Management Specialist

7 days ago


Pune, Maharashtra, India Philips Full time

Post Market Surveillance and Risk Management Specialist

At Philips, we are seeking a highly skilled Post Market Surveillance and Risk Management Specialist to join our team. This role will be responsible for managing activities related to product safety surveillance and risk management, including the review of data from clinical studies and spontaneous complaints for accuracy, completeness, and regulatory reporting.

Key Responsibilities:

  • Review and analyze data from clinical studies and spontaneous complaints to identify potential safety issues.
  • Collaborate with Medical Affairs, Clinical Affairs, Research & Development, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end.
  • Prepare reports on aggregate data and provide recommendations for further escalation.
  • Review complaint trend analysis, product risk assessments, including Health Hazard Evaluations (HHE), clinical evaluation reports, risk management reports, and FMEAs.
  • Assist in benchmarking best practices with world-class organizations, interface with notified bodies, and/or other regulators, and provide input to establish metrics.

Requirements:

  • Bachelor's degree with a minimum of 8 years of experience.
  • Working knowledge of appropriate global medical device regulations, requirements, and standards.
  • Excellent analytical and communication skills.
  • Ability to work in a team environment and provide input to establish metrics.


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