Praveen Sayasrao Munde

As Back up for Team Lead:

• Continuous tracking of workflow and close cases by EOD, handling closure requests
• Worked on different reports and dashboards
• Maintain productivity data for whole team
• Handling team lead activities for managing team of 25 people
• Managing daily workload in conjunction with Pharmacovigilance Manager for individual case processing and other tasks relevant to Pharmacovigilance department
• Plan, organize, and manage daily work to meet service level timelines and deliverables
• Dealing with global PV safety database ARGUS, Arisg and agXchange provided by client
• Work with project lead to discuss issues or tasks outside normal scope of work
• Experience of Literature, Legal, PMS and Spontaneous cases and all other processing in different therapeutic area
• Coding of suspect products with CDD (Company Drug Dictionary) and coding of concomitant, Treatment medicines with WHO Drug Dictionary
• AE / SAE's extraction and Coding of AE / SAE's in MedDRA
• Writing safety narratives, including summarization of essential details of case on basis of source document or data receive on follow up

Job Profile :

Specialized with Legal cases, Spontaneous cases, including licensing partners cases as well as Health Authority cases

As Quality reviewer :

• Peer review the cases and evaluate for accuracy, consistency and completeness in the safety database against the source document.
• This includes, but is not limited to, checking consistency of narrative and other data fields, ensuring main reason for any delay is entered in the routing comment as
  appropriate.
• Review Adverse Event (AE) report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as
  conformity to E2B standards
• Initiate follow-up activities to obtain additional information and clarification, as
  appropriate
• Forward cases for case review or invalid workflow in the global safety database
• Correct the data entry errors, if any, prior to routing the case in the global safety database
• Track and document all observations and recommendations on the defect
  tracker

Job Profile :

Specialized with medical/scientific literature cases, PMS cases, including licensing partners cases as well as Health Authority cases

As a Subject-Matter Expert :

• Design, build, manage and provide day to day operational oversight and support to drug safety and Pharmacovigilance system. Develop and maintain standard operating procedures related to drug safety and Pharmacovigilance.
• Ensure compliance with national, regional, global drug safety, risk management regulations and code of conduct.
• Proactively monitor medical and scientific literature for published articles relevant to the safety profiles of product of interest to our client.
• Evaluation of adverse event (AE) report data for completeness and validate certain fields to determine as critical as well as conformity to E2B standards.
• To kick-off the pending internal and external queries, following up with sites regarding outstanding queries and keep the project in pipeline.
• Follow up on reconciliation of discrepancies and provide RCA and implement CAPA in case of any process deviation.
• Train and provide assistance to data entry and peer reviewer team in order to ensure highest quality (taking hurdles, interaction with client for the queries).
• Direct interaction with client on a daily/weekly basis calls/conferencing, complying with additional requirements from client (providing answers to queries raised by central processing team, implementing changes as they occur, participating in report corrections).

As Quality reviewer :

• Peer review the cases and evaluate for accuracy, consistency and completeness in the safety database against the source document. This includes, but is not limited to, checking consistency of narrative and other data fields, ensuring main reason for any delay is entered in the routing comment as appropriate.
• Review Adverse Event (AE) report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards
  Initiate follow-up activities to obtain additional information and clarification, as appropriate
• Forward cases for case review or invalid workflow in the global safety database
• Correct the data entry errors, if any, prior to routing the case in the global safety database
• Track and document all observations and recommendations on the defect tracker

Job Profile :

Specialized with Spontaneous cases, PMS cases, Device cases, Spontaneous Cases, including licensing partners cases as well as Health Authority cases

• Confirms case validity, responsible for data entry of Individual case safety reports into safety database
• Directed collection, data entry, coding, routing, reporting, and market research of safety information in compliance with regulations
• Reviewed, assessed, triaged, processed, and reported adverse event reports according to applicable regulations, guidelines, SOPs, and project requirements within specified timelines by meeting quality standards
• Performed review of spontaneous case reports concerning adverse and serious events to ensure accurate data capture according to SOPs
• Ensured that duplicate check is conducted against Global Safety Database in accordance with SOPs for all ICSRs in order to determine whether there is existing case file
• Prioritized adverse event reports processing based on clock start dates
• Performed safety data entry in database, coded relevant medical terminology, wrote descript narratives, generated queries pertinent to case, and ensured case reporting
• Managed responsibility for verifying work flows and maintained TAT of cases assigned to fellow associates, attended project team meetings and client calls related to project and performed other duties as assigned.