Barun Sen

Background

About Barun Sen

Worked in Wipro Limited as a Complaint Handling Specialist in Medical Device Reporting having experience of 2.5 years in Materiovigilance. Currently working as senior L1 investigator. Job responsibilities:*As a Complaint Evaluator my job roles include: Owning the complaint handling process including- 1. Complaints evaluation including adverse event reporting decisions, coding, initiating Good Faith Effort (GFE) follow up for additional information and closure of records. Assessment of Complaints(events) for proposed MDR reportability and submit assessments to client or regulatory authority. Assessment of the accurate Hazard code 4.Reportability assessment 5. Failure code assessment 6. Risk level assessment 7. complaint review and closure *As a Complaint Investigator my roles is: 1) Reviewing the records assessed by Evaluators 2) Investigating complaints 3) Writing of Investigation summary and Notes 4) Problem Source and reason code assessment 5) Creating Customer Response and market submitter response letter 6) Handling CAPA