Safety Software Engineer

Summary

** ***** ** ** ********** including ** years of expertise in the Life Sciences, Pharmacovigilance (PV) domain. Expert in managing cross-functional teams to evaluate business processes and lead the implementations of companywide technical solutions. Track record of successfully handling the product management, managed services and client services for the delivery of Intake and Safety solutions (PVAI Intake, Argus/J Safety suite, custom reports, and in-house custom solutions). Steered application development with quality output while directing remote and geographically distributed teams. Collaborative partner to senior management – influencing buy-in, and explaining technical terms to non-technical personnel. A visionary, mentor, and target-driven professional with a knack for driving efficiency.

Areas of expertise:

Safety system Implementation

Application/Technical support

Change Control Management

Cross-Functional Team Leadership

Project Management

Data Migration and integration

End-User Training

Pre-Sales support

Business Analysis

Business process design

Vendor management

Computer System Validation

Professional Experience

Lead transformation program for the automation of DSU/DSO workload management, Adverse Event (AE) Case Intake to Case Processing and Submission through AI platform

Expert in the implementation of Safety System including Oracle Argus Safety, Argus J and complete safety suite (with strong knowledge Argus database architecture) for case processing, periodic and expedited report submissions (CIOMs, MedWatch, and E2B)

Conduct configuration room pilot (CRP) to finalize the business configuration, including workflow rules, security management with user groups and site configuration, code list, company master data (including product, study, license and WHO Drug and MedDRA Dict.)

Strong understanding of E2B reporting and Oracle Argus Safety ESM/E2B architecture for sending ICSR information electronically to License Partners and Health Authorities (FDA, PMDA, and EMA) with EDI Gateway Cyclone

Manage stakeholder expectations and facilitated key meetings with senior management, reporting status, providing direction and feedback to all teams

Spearhead the analysis, design and build phases of product development and delivery

Act as a liaison between system team and global Pharmacovigilance business (GPV) team to capture and translate business requirements into a technical solution

Strengthened the vendor management program by acting as a primary liaison between the GPV system team and multiple vendors to coordinate delivery, maintenance of computing infrastructure and upgrade of MedDRA and WHO Drug Dictionary

Manage the migration and upgrade projects for the mapping of the legacy data and configuration with the targeted software

Drive the implementation of a solution for areas of technical and process improvement by partnering with cross-functional and IT teams

As a Safety System owner, committed to the internal and external audit by providing details of system data flow, system demo and response CAPA requests

Direct the validation team to execute the validation cycle, including finalization of the testing strategy, test scenario, test data, and bug life cycle

Propose and influence senior leadership buy-in for prioritization of issues using business criticality and risk-based approach

Mentor the cross-functional teams to improve the system and domain knowledge.

Explore potential business opportunities within the program and proactively provide proposals to clients based on their initiatives

Significant Project Experience

Genpact Jun 2018 – Present

Assistant Vice President – Client Services

Achievements:

Lead the analysis phase for the understanding of the current business processes and current pain areas to finalize the business requirements and TO BE business process.

Head the session between business users and product strategy team to finalize the scope of out of the box features, business specific customizations, and configuration to meet the business needs.

As a domain champion, articulate the business scenarios and transfer domain knowledge to the AI team to train the machine learning models for continuous improvement of the accuracy of ML models.

Proactively support the data migration team for the mapping of legacy system data to the target system data model.

Based on CFR Part 11 compliance, spearhead the end to end development and delivery of the reporting module including reconciliation reports, compliance monitoring reports, vendor oversight reports and ML model performance report to support inspections, audits and health check of the system and business process.

Finalize the validation plan with stakeholders, coach the validation team on business requirements and to write test scenarios, test data, IQ, OQ and PQ, resulting in improving the quality of the test script and test data.

Implement continuous defect review with stakeholders to prioritize and disposition of defects for go-live and post go-live release; leading into high visibility of critical defects early in the implementation phase and identifying the next steps to handle them.

Vitrana Inc Apr 2017 – Jun 2018

Manager Safety System - Argus SME

Achievements:

Streamlined the vendor management process by developing daily, weekly and ad-hoc reports resulting in increased efficiency of the case processing vendor.

For a CAPA response of an audit finding, took an initiative to transform the data entry process of structured AE source documents by automation, resulting in efficiency improvement of data entry workflow and avoided late case processing.

Orchestrated the migration of the Japanese AE from existing safety system to Argus Safety system via re-engineering of previously submitted PMDA E2B reports.

Redesigned the Japanese case processing workflow in Argus/J Safety to optimize the global case processing and submission of compliance reports to regulatory authorities (PMDA, EMA, and FDA).

Created the system operational procedure (SOP) and guidelines for system and business team.

Assessed and implemented the Transform PV instead of Argus 8.0.2 upgrade for E2B R3 submission to meet regulatory deadlines with no impact on the current business operations and a reduced budget.

Managed the validation documents, in accordance with audit standards, including validation plans, traceability matrix, OQ, PQ, IQ, and validation summary.

Strengthened the program management function by partnering with a vendor to design the Managed Service Model (MSM). Included SLAs for various services, staffing procurement, a skills matrix, communication protocols, and escalation channels.

Oracle America Oct 2010 – Mar 2017

Principal Consultant – Argus SME

Achievements:

Finalized the configuration of Argus Code List, Product, Study, and license (PSL), user, group, and workflow rules by conducting the CRP.

Conducted the gaps analysis workshops to understand the current business process, identify the gaps in Argus J OOB functionality and design the custom solutions to fulfill the gaps.

Mapped and upgraded the existing E2B import/export profile (EMA, FDA and business partners) to target version Argus Safety 7.0.3 with no business impact.

Finalized the PMDA E2B reporting requirements and implemented the PMDA E2B profile for Japanese reporting.

Created an optimized solution for Japan case processing as an alternate of Argus J for PMDA reportable cases resulted in reduced case processing time from 15 days to 3 days

Foresight Group Aug 2009 – Oct 2010

Sr. Principal Consultant – Client Services and Validation Lead

Achievements:

Executed the validation activities including the preparation of validation plans, efforts estimation, preparation and execution of OQ, PQ, IQ and validation summary.

Prepared the Argus Safety testing environment for testing activities.

Relsys International Inc. (Oracle Health Care Business Unit) Apr 2007 – Aug 2009

Validation Lead

Achievements:

Test Plan preparation, defined test strategy, effort estimation, prepared and executed the OQs and IQ.

Prepared the test environment, including the installation of the Argus Safety suite (Argus Safety, AG Service, ESM Service, ESM Mapping Utility and Argus Insight) and Axway for the transmission of messages across Trading partners/Agencies.

Prepared the requirements traceability matrix, bug reporting and bug tracking.

Early Career Mar 2003 – Apr 2007

Validation Lead – HCL Technologies, OMX stock exchange, Sweden

Software Engineer – R Systems, India

Education

U.P. Technical University Lucknow, India (2000- 2003)

Master of Computer Application (MCA)

MCRP University Bhopal, India (1997 – 2000)

Bachelor of Computer Application (BCA)

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