Aditya Anil Khilare

• 1. Perform Review, evaluation, classification, reportability criteria and follow up activities on medical devices product complaints. Summarize investigation results based on technical analysis.
• Receive complaint information, evaluate and database it. 3. Perform Failure coding, Event coding, Hazard coding activities.

• Follow up to gather more information and handling product returns activities.
• Assess complaints to determine if complaint meets reportability criteria for submission to Health Authorities.
• Perform trend analysis by utilizing complaints data from database of a specific period.
• Write investigation summaries based on technical product analysis data. 8. Work with other teams such as Investigation and QA teams.
• Review and perform activities related to complaint closure.
• Notify the supervisor or Information Security officer of any security breaches/incidents. 12. Any other responsibilities including crossfunctional assignments delegated by the organization to fulfil business needs.

Case intake/triage

• Confirm validity of case by identifying minimum criteria for case creation
• Perform duplicate search to create either an initial case or a follow-up case
• Understanding the principles and concepts associated with patient safety case-handling process including regulatory requirements for reporting individual case safety reports
• Identify serious adverse events and special scenario cases which includes lack of efficacy,exposure, and pregnancy case, at risk cases, and product quality complaint only cases
• Attach the relevant source documents or any safety information/queries/follow-up information that is relevant to the case
• Facilitate follow-up based on queries from data entry/QC/MR or based on inconsistent/missing information in the source file

Case Processing

• Responsible for data entry of individual case safety reports into Argus Safety database
• Responsible for coding which includes adverse event, medical history, Lab data, Indications narrative, selection and detailing of adverse events,action taken, dechallenge and rechallenge, medical history and diagnostic details using standardized terminology from a medical coding dictionary, such as MedDRA
• Code products (Suspect/co-suspect, Concomitant) as per Client conventions
• Process all incoming cases in order to meet timelines
• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields
• Delivering the ICSR on various case types including Regulatory Authority,Clinical trial, Spontaneous,Post market survey , Literature study
• Sent all types of query to client for confirmation,sent translations mails and sent acknowledgement mails

• Experience of handling medical records.Knowledge of ICSR case processing, receipt of review,and tracking of ICSR received from regulatory authority (UKMHRA, Eudravigilance, Canada Vigilance)
• Perform a duplicate search
• Responsible for managing the pharmacovigilance group's daily operations, including the receipt and processing of adverse event reports and medical inquiries
• Perform the daily tracker update, send batch number confirmation to the client, send daily translations for regulatory cases, Send acknowledgements
• Weekly reconciliation of regulatory cases
• Send confirmation of void, nullification, and deviation
• Prioritize ICSR according to regulatory requirements
• Carried out day-to-day duties accurately and efficiently