Ankit Dutta

Managed the receipt and processing of all adverse event reports reported either spontaneously from any source. This includes, but is not limited to: entry of safety data into the adverse event database(s) and tracking systems

Reviewed adverse events for completeness, accuracy and appropriateness for expedited reporting.

Identified clinically significant information missing from initial reports and ensures its collection.

Performing quality review of ICSR for Solicited and Spontaneous cases.

Provided appropriate feedback to case processor.

Ensure that data entry errors are corrected prior to routing the case in ARGUS (Modify case data as needed).

Identified and updated Change in Composition of Raw materials using Concerto and RMQ Portal and supplier documents.
Supported RM management activities to comply global regulatory requirements.
Addressed complex regulatory activities in support of submissions and ensure compliance of operations with governing regulatory requirements.
Driving communications with various internal departments, viz. Procurement, Analytical, technical assurance and External Manufacturer/supplier, sites to understand change, implementation strategy and procure require documents to assist the governing change.
Implemented use of consistent, efficient and quality process to meet timelines and deliverables according to regulatory requirements.
Ensured compliance of operations with governing regulatory requirements
Created and/or updated Raw Material Questionnaire (RMQ) using RMQ database.
Prepared WHERE-USE reports from TRU database needed for assessing Intended selling region, Manufacturing region of RAW material essential for identifying qualification region (APAC,NA,LATAM,EMEA) of the RAW materials.

Managed the receipt and processing of all adverse event reports reported either spontaneously from any source. This includes, but is not limited to: entry of safety data into the adverse event database(s) and tracking systems

Maintained a strong understanding of safety database conventions or client specific database conventions, as appropriate.

Maintained a comprehensive understanding of Safety Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.

Coded adverse events accurately using MedDRA.

Worked under Workflow monitoring team to receive ICSRs in client workflow and change the Global receiver unit so that the ICSRs can be transferred to Covance workflow for further processing and reporting.

• Data entry of ICSRs, including spontaneous, E2B, literature, internet source cases following the criteria set by the client
• Verify the accuracy and consistency of data entered against the source document and ensure data consistency between free texts entered in the narrative and all structured case form fields
• Promoted to Quality reviewer role on Jan-2020, after which doing quality review of cases processed by Case processors, giving them feedback about cases processed guiding them along with their query that occurs during case processing.
• Learn and deliver for maintaining the individual quality and productivity numbers, for betterment of individual performance as well as team's performance
• Resolving problems, query and issues encountered by case processors.
• Conducting daily huddles, refresher trainings for the team to update the team with new case processing conventions that are communicated from the client, discussion of errors received during client audits so as to improve the overall quality parameters of the team.

• Processing of spontaneous cases of European, American and AsianLOC
• Processing of PMS cases of all theLOC's
• Processing of Literature PMS and spontaneouscases
• Processing of E2Bcases
• Processing of clinical trial cases of various protocols (both SAE forms andfrom MEDIDATA (RAVE) forms as well as hospital discharge summary cases
• Conversant with Argus 8.1.2database
• Triaging and booking of cases
• Hands on experience on Medical coding of adverse events in Medra as well as drug (suspect, cosuspect and conmeds) coding in both WHO dictionary and company product dictionary and assessing of causality of adverse events related to suspectand co-suspectdrugs
• Writing of medical narrative of all sorts of cases (PMS, spontaneous, literature,e2b and clinical trialcases).