Naveen Basar Email & Phone Number

Dublin, County Dublin, Ireland

At Biologit, I've excelled in roles that revolve around leveraging artificial intelligence tools within the life sciences and pharmacovigilance domains: Translated intricate client requirements into AI-powered feature enhancements and services. Acted as the vital link between stakeholders and our AI-driven solutions, effectively championing customer needs. Prioritized AI-driven product changes, aligning them with the evolving demands of the life sciences and pharmacovigilance landscape. Orchestrated cross-functional collaborations to position our AI-powered solutions competitively and resolve industry-specific challenges. Leveraged project management tools for seamless AI project monitoring and tracking. Ensured rigorous adherence to regulatory standards and compliance within the dynamic realm of AI in life sciences. Led Quality Assurance initiatives with a particular focus on AI-driven systems, including Computer System Validation. Facilitated smooth client onboarding within the context of AI-powered solutions, ensuring seamless integration. Elevated AI model performance in the realm of pharmacovigilance, driving precision and recall improvements. Engage in Risk Management activities, identify AI risks, and suggest risk mitigation strategies. Results-driven Customer Support Owner with a proven track record in configuring JSM, and hands-on issue resolution. Committed to elevating customer satisfaction through strategic leadership and continuous improvement initiatives. Crafted AI labeling strategies and training datasets, equipping our teams to train AI tools for optimized handling of adverse events and safety signals.My journey at Biologit has been defined by a relentless commitment to harnessing AI tools to advance the fields of life sciences and pharmacovigilance, ensuring that our solutions not only meet but exceed industry standards and customer expectations.

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Dublin, Ireland

At biologit, responsible for• Frequent interactions with early adopters and seek the feedback and requirements.• Translate the client requirements to AI Engineering team/Data Scientists.• Project Status: Monitor, track, followup with action plan for all the sprints .• Request Change proposal based on client requirements.• To make sure the tool is meeting industry standards and be compliant with EMA and FDA regulations (21CFR part 11).• Participate in Computer System Validation (CSV) Tasks of the tool under development.• Write Test Scripts and perform the user acceptance testing at all stages.• Develop/Design the SOPs for each development phase of the tool.• Identifying the bugs and logging the tickets and followup for the resolutions from Engineering Team.• Interacting daily with AI Engineering team (Data Scientists and Engineers) to present the issues and scenario to fasten the solutions.• Perform Error Analysis, find the root cause for false negatives and false positives, and provide the solutions.• To provide continuous training to team on all requirements and to stay up to date on EMA/FDA regulatory guidelines.• Perform Quality Audits and quality checks of the annotators and provide constructive feedbacks.• Implement Corrective and Preventive Action plan to maintain the quality and adhere to standards/SOPs of the AI Tool at all phases.• Prepare Interannotator Agreement Report using Cohen’s Kappa formula.• Eliminating non-value added tasks.• Act as a trainer for AI Tool: Use the subject matter expertise to test AI tool performance and quality of the output and suggest the changes in AI models (including quality of capturing valid cases of adverse events/ADRs (serious vs non-serious) for ICSRs, special situations, data requirements for aggregate reports, safety signal detection, etc).• PV Responsibilities to support QPPV: Designing all PV SOPs, including DSUR/PSUR, Signal Detection, Serious Breach, etc

India

Responsible for managing a team of 30 members working on pharmacovigilance medical literature review/monitoring tools, Actively engage with internal and external stakeholders to understand business or user requirements and collaborate with the Engineering team to implement further enhancements/redesigning the tool as per the client's requirements. Drive the team in designing Test Scripts/execution for every release of the product/tool.Assume responsibility for Quality in all Pharmacovigilance literature tasks, encompassing the handling of individual case safety reports, collation of adverse events from post-marketing clinical studies, drafting clinical summaries, and producing clinical evaluation reports for Medical Devices. Additionally, oversee the creation of medical charts for record maintenance and research. Lead a team focused on tools monitoring Trademark/Brand infringement, ensuring excellence in customer

Hyderabad Area, India

Supported a team of 20 members working on medical literature review/monitoring, literature individual case safety reports, capturing adverse events from post-marketing clinical studies and writing clinical summaries and Clinical Evaluation Reports (from literature) and preparing physician-directed medical charts. As a process lead, with major role is to manage the team's quality:1. Continuously improved the quality with frequent quality audits and by identifying critical defects using quality tools including Pareto charts, fishbone analysis, and brainstorming.2. Initiated/implemented quality improvement ideas to redesign the quality control system and improved the quality from 97.5% to 98.5%.3. Managed the volumes in the absence of resources by involving in the production.4. Received star award for outstanding team's performance.5. Identified prospective customers and turn them to the company's customers with the support of manager.

India

India

Reviewing or performing quality check of all Electronic Medical Records against original paper based medical charts/dictations by physicians from US and Canada Hospitals. Medical Record included but not limited to patients’ history and physical, diagnosis, treatment plan (medication list) and medical imaging reports. Worked on records with specialties of interest included but not limited to cardiology, orthopedics, gastroenterology, hematology/oncology, emergency medicine, surgery/radiology, pulmonology, psychiatry/psychology, workmen’s compensation reports, ENT, neurology, etc.

India

Bsc, Lifesciences

Bsc Life Sciences

Master Of Science (Msc), Microbiology, General

Msc Microbiology

Quality And Timeliness

Education record

Drug Safety