Indrani Dutta
Senior Safety Vigilance Specialist at 4c Pharma Solutions
Based in Bengaluru, India
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Seniority
Staff
Department
Other
Location
Bengaluru
Industry
Pharmaceutical Manufacturing
Company size
171
Contact information
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i•••••••@4cpharma.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Indrani Dutta
Working as Vigilance Reporting Specialist 4C Pharma Solutions having experience of 4+years in PV and MDV. Job Description:* Handling ClassII Medical Device complaints *Receiving, reviewing and evaluating complaints and doing the FDA submission of the reports.*Identification and documention of serious/non serious incidents *receiving recording information *evaluating the information to determine if the feedback constitutes a complaint *investigating complaints *determining the need to report the information to appropriate regulatory authorities *handling of complaint related to product *determining the need to initiate corrections and corrective actions *Train the Team regarding the process. Following USFDA Guidelines, ISO 13485
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