Pankaj Patil

Business Analyst (R&D-Clinical Research Automation)

• Requirement Elicitation: functional, Non-functional, design & software requirements after discussion with clients stakeholders.
• Creation and updating of requirements in Azure DevOps dashboard in the form of EPIC, features, PBIs
• Documentation: System specification, BRD, Operational Manual, User Requirement specification, Traceability Matrix, Change request document which helped to run the process smoothly.
• Worked in AGILE environment using Agile methodologies & SDLC.
• Handled a work as Domain consultant, SPRINT creation and update.
• Close interaction with Developers, Data Analysts, Data Scientists, Solution Architect & provided life science/Pharmacovigilance/clinical research training to all
  for better understanding of aim & expected output.
• Guide and support to R&D stakeholders to develop new and innovative products that have the potential to improve patient outcomes.

Business Analyst (Pharmacovigilance Automation)

• Requirement Elicitation: functional, Non-functional, design & software requirements after discussion with internal stakeholders.
• Fixed 570+ Bugs/Defects (raised by HRM: Human Reading & Mimicking AI tool) which impacted on drastic improvement in ICSR processing time from 35 min average to 7 min average.
• Review and feedback sessions to developers with explanations and training related to PV concepts for the extracted outputs received from them which helped developers to automate the process smoothly.
• Resolved outputs and removed roadblocks that were impacting on slowing down the process especially adverse events, medical history, and laboratory data.
• Preparation and review of requirement documents, change request forms for Pharmacovigilance case processing source documents (CIOMS, MedWatch, SAE Excel, E2BR2).
• Study on-boarding activity.

• Handled a team of 23 people.
• Implemented effective ideas in project for good quality and productivity under six sigma.
• Client responsiveness and management of daily workload for ICSRs.
• Performed impact assessment on emerging regulations.
• Conflicts management within the team.
• Built strong relationships with customers through positive attitude and attentive response.
• Conducted training and mentored team members to promote productivity and commitment to friendly service.
• Mentored and guided employees to foster proper completion of assigned duties.
• Established open and professional relationships with team members to achieve quick resolutions for various issues.
• Communicated KPIs outlined in annual plan to inform employees of expectations and deliverables.
• Assisted in recruitment of new team members, hiring highest qualified to build team of top performers.

• Performed Quality Analysis & Data Validation to assess accuracy of data.
• Book-in of SUSAR cases, Case processing & Quality review of the Clinical trial, Spontaneous, and Orphan drug cases on ARGUS.
• Timely issue escalation and response both internally and at the client level.

• ICSR (Cosmetics) Case processing and Quality review.
• Collaborated with business-unit leaders to identify and prioritize problems.
• Documented effective and replicable methods for extracting data and organizing data sources.

• Spontaneous, LP, Pregnancy, and Active Moiety cases: - End-to-end Case processing - Assessing the validity of the case
• Expedited lists- Checking daily expedited lists
• Ensuring the accurateness of the list - To evaluate causality and compliance with drug safety issues in an environment with complicated and frequently changing regulatory requirements and guidelines
• ARISg Experience - Clinical Trial, SUSAR Cases: - Quality review for Oncology Clinical trial cases using the EDC system to increase the data accuracy, Narrative review
• Performing De-challenge and Re-challenge
• Coding of events, suspect products, concomitant medications, history, indications, etc
• Nexus CRO – Hands-on Project
• Department - Trial Management and Operational
• Client - Venus Remedies, Hands-on experience as a Clinical Research Coordinator on a pilot study of oral herpes, and a comparative study of a US-FDA trial on bacterial infection after surgical prophylaxis under the supervision of Dr
• Amit Bhatt for Nexus clinical research Pvt ltd, Data Science Projects/Case Study - Created case studies on sales prediction
• Analysis work for a human resource on employee attrition rate.