Raviraja Ankathi

• Overall experience: 10 years in the fields of pharmacovigilance and drug safety, with expertise in testing new software tools for processes and pharmaceutical market research/analytics.

Previous Designation: Medial Services Analyst Duration: Oct 2016 to Dec 2018.

Safety Database: Oracle Argus, ARISg, SCEPTRE and PRIMO.

Job Responsibilities:

• Perform In-line Quality checks on ICSRS entered in Global Safety Database in accordance with applicable KPIs or Service Levels and regulatory day and as agreed with client.
• Confirm that the information in the Global Safety Database is accurate and consistent with the Source Documents. Confirm the accuracy of terminology, coding and manually. Confirm the accuracy of RPA BOTs used in selected cases and PV AI cases after CP.
• Recode any errors or inconsistencies as needed. Determine if any follow up or additional information is needed and take all relevant steps to obtain any additional/missing information.
• Perform Quality checks as per the agreed quality parameters and provide feedback to the team members for findings, ensure the corrections have been performed and document the results.
• Analyze the errors in data entry, identify the root cause (RCA), formulate and implement corrective and preventive action (CAPA) as part of Error trend analysis as per SOPs.
• Act as a SME to the team, coordinate /conduct session as a part of CAPA and refresher training as per the team's requirements and document the trainings. Coordinate with Quality assurance (QA) team in timely closure of SLA QC findings.
• Review and complete case suppression/ nullification as appropriate.
• Works closely with the team leads, tower leads and client, respective stake holders for the timely resolution of quality issues. Identify, support, and implement continuous improvement activities.
• As an SME in project take up ad-hoc activities whenever required like UAT for new tools, interview process and training of new candidates. Escalate issues or tasks outside the normal scope of work.

• Perform In-line Quality checks on ICSRS entered in Global Safety Database in accordance with applicable KPIs or Service Levels and regulatory day and as agreed with client
• Confirm that the information in the Global Safety Database is accurate and consistent with the Source Documents
• Confirm the accuracy of terminology, coding and manually
• Confirm the accuracy of RPA BOTs used in selected cases and PV AI cases after CP
• Recode any errors or inconsistencies as needed
• Determine if any follow up or additional information is needed and take all relevant steps to obtain any additional/missing information
• Perform Quality checks as per the agreed quality parameters and provide feedback to the team members for findings, ensure the corrections have been performed and document the results
• Analyze the errors in data entry, identify the root cause (RCA), formulate and implement corrective and preventive action (CAPA) as part of Error trend analysis as per SOPs
• Act as a SME to the team, coordinate /conduct session as a part of CAPA and refresher training as per the team's requirements and document the trainings
• Coordinate with Quality assurance (QA) team in timely closure of SLA QC findings
• Review and complete case suppression/ nullification as appropriate
• Works closely with the team leads, tower leads and client, respective stake holders for the timely resolution of quality issues
• Identify, support, and implement continuous improvement activities
• As an SME in project take up ad-hoc activities whenever required like UAT for new tools, interview process and training of new candidates
• Escalate issues or tasks outside the normal scope of work, To perform quality review of processed cases and other duties as assigned for quality review
• Perform UAT for PRIMO tool for Argus
• Receive, triage, review and process data from various sources on time and meet quality standards
• Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines
• Mentoring and provide training to less experienced or newer staff members
• Involves important decision making for entering the case in to the data base, processing the patient data, assessing the seriousness, monitoring the adverse events, coding the events with the help of MEDdra, labeling the events according to the Company Core Data Sheet and product monographs approved by regulatory authorities of different countries
• Write the narrative in a chronological format and do the quality check of the cases processed before reporting to the regulatory to avoid reporting of the incorrect data and by maintaining the confidentiality of the patient details
• Leading the employee engagement team
• Conducting and participating actively in employee engagement related activities.

• Perform initial checks and search database to prevent duplicate entries and ensure verification and validation of source document.
• Gather market and business information creatively using internal and external research sources for pharmaceutical companies.
• Quality review is performed as and when needed and providing training for new joiners.
• Experience in handling client quires regarding database information and sending clarifications for the same.
• Secondary research using USFDA, EMEA, Clinicaltrials.gov, Pub Med and other drug regulatory authorities of countries through web, information services, publication database and patent database to collect daily product updates specific to the companies and their competitors.
• Collection of day-to-day information on product development and company status from recent news and from SEC Files (Annual and Quarterly Reports).
• Participating in Management activities necessary arrangements for internal audits.
• Training new joiners for the team.