info@pharmajobalerts.co.in
Executive, Post Marketing Surveillance (Vantive)
6/3/20261 min read
Roles and Responsibilities
Job Summary:
Post-market surveillance involves collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings. The Post Market Surveillance Trainee will be responsible for evaluating potential product quality complaints, initiating timely actions in association with coordinating the investigation to complaint closure. Ensure applicable, local, national and international regulatory requirements and internal expectations are met.
Essential Duties and Responsibilities:
Evaluate potential product quality complaints and initiate applicable records and actions within proper Quality System.
Own and process quality complaint as per applicable procedures.·
Determine, facilitate and/or approves reportability assessments and decisions based on applicable procedures.·
Author and submit applicable regulatory reports (MDR, MIR, etc.) to competent authorities when deemed required.·
Monitor the status and progression of complaints under investigation and initiate actions to facilitate its resolution and closure.·
Review and approve the results of Engineering, Manufacturing, Quality, Service and/or Supplier evaluations and investigations of complaints.
Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints to drive continuous improvements within the department and organization.·
Performs other duties as needed and assigned.
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