Prabhjot Singh Nandre

Experience

• 

  IQVIA

  Jan 2011 - Sept 2016

  • Oversee Pharmacovigilance operations, ensuring that department deliverables meet expected quality, financial and productivity targets.• Ensure that progress is being made, and that corrective action is taken if necessary.• Responsible for recruitment, hiring, terminations and performance management.• Examines reports (e.g., inventory, productivity, and quality reports) to determine the operational activities of the department and ensure optimum performance.• Conduct annual appraisal for direct reports.• Mentor Assistant Managers and Associate Managers.• Leading and encouraging direct reports in continuous improvement of department work processes and infrastructure.• Instructing and leading direct reports in efficient management of project budgets. Show less • Manage Pharmacovigilance staff in accordance with organization's policies and applicable regulations.• Responsibilities included planning, assigning and delegating work to the team members.• Appraising performance and guiding professional development for staff.• Rewarding and addressing employee issues. Approve actions on human resources matters and effectively resolving issues.• Monitoring and motivating staff to achieve and maintain acceptable levels of performance.• Resource planning for current and projected projects to ensure deliverables are met.• Collaborating with other department managers to address problem areas, staffing needs, equipment needs.• Conducting staff training and ensure the following Standard Operating Procedures (SOPS), Good Clinical Practices (GCPs), FDA/EMEA and ICH guidelines and regulations are strictly adhered to.• Identify improvement opportunities to optimize processes, decrease costs and increase client value. Show less • Responsible for logging and tracking of requests for database queries and support in generation of listings and reports for: ad hoc query requests, in support of aggregate periodic reporting (PSURs, PADERs, SUSARs, and PBRERs) and surveillance signal detection.• Responsible for working with Local Safety Officers to troubleshoot problems with case reports to ensure regulatory compliance.• Support global Regulatory Inspections by providing accurate and timely listings required for submission.• Develop and maintain Standard Operating Procedures, Working Practices, and Guidelines which detail the consistent and appropriate handling of safety data.• Create, implement, and review training and development plans for team members and mentor new beginners and support their onboarding so they can excel in their roles.• Develop, maintain, and review to monitor daily workload with a focus on quality and timeliness.• Interface with internal and external customers, ensuring that team members are compliant with written procedures and guidelines while contributing to or leading a project team on behalf of the site.• Liaison between business Subject Matter Experts and Technical Team for trouble shooting safety database issue.• Additional responsibilities include performing data quality checks along with writing and performing user acceptance tests (UAT) for system enhancements and modifications. Show less • Receive, triage, review, and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology (MedDRA), writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations, and ensuring reports are sent to the customer within assigned deadlines.• Preprocess material for endpoint committee or core laboratory adjudication.• Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local offices to facilitate expedited reporting.• Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.• Assist operations team with tasks, provide for back up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes.• Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate.• Liaise with different functional team members, e.g., project management, clinical, data management; health care professionals e.g., investigators, medical monitors, site coordinators and designees to address project related issues.• Subject Matter expert (SME) for ARGUS (safety database) transition and implementation on site: core member in preparation of content development for staff. Provide training to staff and monitor the operations throughout its implementation. Show less

  • Associate Manager

    Apr 2016 - Sept 2016

  • Assistant Manager

    Nov 2014 - Mar 2016

  • Operations Scientist

    Apr 2014 - Nov 2014

  • Senior Associate

    Jan 2011 - Mar 2014
• 

  Syneos Health

  Sept 2016 - now

  • Accountable for designing, developing, and deploying visualizations and reports to interrogate data sets and provide business insight which effectively communicate information to users. • Understand requirements from multiple business stakeholders and effectively work with both technical and non-technical audiences. • Build and deploy scalable data visualizations and dashboards leveraging big data stores and warehouses.• Part of the Product Development team as a business process SME instrumental in design, development, testing and roll out of an enterprise-wide platform PV HUB for end-to-end pharmacovigilance service delivery platform across all Case Management activities Case intake, Case processing, Quality management, Submissions with Reporting and Analytics.• Support application engineering team with business requirements and used cases for an Agile application build.• Provide business expertise to DevOps team during sprint review cycles/ meetings.• Develop user acceptance test strategies for deployment of product features for successful deployment in production environment.• Support product owners and process champions to deliver committed return on investment through application adoption and performance.• Provide analytical insights for departmental performance management and revenue realization. Show less • Part of a focused Catalyst team responsible to establish and manage effective Solutions, Product Management and Operational Effectiveness Services (OES) structure and relationships to maximize engagement, revenue growth and value within Strategic Resourcing Group (SRG).• Develop products/services as offering for big and mid size pharmaceutical companies to outsource services to Syneos Health and help the establishment of large, complex, cross functional projects and initiatives directly affecting the operational and financial success on Strategic Resourcing Group (SRG) return on investment.• Drove ongoing efforts to improve productivity and service levels commitments through utilization of tools, management training, and staff performance. Orchestrated and scheduled quarterly initiatives. Working with Six Sigma and Lean processes for making the operations effective and balanced.• Developed an efficient service delivery model by optimizing current core competency. Detailed capability assessment on people, process, and technology re-baselining with focus of continued engagement with current customers and reduce delivery costs through standardization and elimination of redundant efforts and reduced cycle time. Qualitative and Quantitative analysis, which help, determine areas of opportunity for improvement and pain areas from automation perspective.• Reduction in effort intensive activities, capacity planning and management leading to organizational savings. Show less

  • Associate Director

    Oct 2022 - now

  • Associate Director

    Nov 2018 - Oct 2022

  • Manager

    Sept 2016 - Nov 2018