Naeem Shaikh Email & Phone Number

Hyderabad, Telangana, India

Apply advanced analytical methods and data science to assess safety data, enhance safety assessment, and drive drug discovery.

Hyderabad, Telangana, India

Drive the implementation of data analytics reports and dashboards for optimal data review. Translate business requirements into logical models and provide direction to the development team. • Participated in development and maintenance of Clinical Supplier Insights Tool: Supported with vendor engagement, backend development, data review and analysis.• Supporting development of rule file utility meant to simplify the Rule File creation activities of applying different logics for transformation of Source data (EDC & Third Party).

Hyderabad, Telangana

Reporting & Analytics of Clinical & Operational Data. Produce and track reports for various line functions, used for ongoing monitoring of clinical data, Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.• Clinical Suppliers Insights: Enterprise reporting tool providing operational metrics on conduct of clinical trial. Supported team with design, vendor engagement, data analysis and backend development.• COVID-19 Site Surveillance Tool: Intelligence tool aimed at mitigating COVID impacts to development pipeline. Supported team with data analysis, backend development, end to end review, error handling and maintenance. • Developed report for suggesting MedDRA Queries for safety data review. • Developed report to identify applicability and utilization of edit checks.

Hyderabad Area, India

Participate in the life-cycle of producing key data and/or reports in support of data review reporting development along with providing quantitative analytical support.• Developed report for reconciling free text field across domains (AE/CM) using NLP.• Developed NLP based assistance tool for MedDRA coding and review.• Developed tool for automating exhaustive test case creation and its analysis.• Performed sentiment analysis and topic modeling on internal employee feedbacks.

Hyderabad Area, India

Ensure quality and timely clinical data delivery for clinical trial projects and establish appropriate application of data standards & perform quality assurance review of key clinical data management deliverables.• Supported large Phase III clinical trial with data review, reconciliation, and query management. • Developed python scripts for automate manual review process which significantly reduced processing time. • Supported other 3 clinical trials.

Hyderabad Area, India

Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety reports (Periodic Safety Update Reports PSUR/PBRER) for Novartis mature portfolio: collecting, organizing, analyzing and presenting the safety data in accordance with international guidelines (ICH E2C(R2) & GVP Module VII (R1)).• Co-authored PSUR on a vaccine. Supported multiple reports with the analysis.

Mohali Sub-District (S. A. S Nagar), Punjab, India

PhD Research Project: Applied predictive modeling (machine learning) & data mining to identify therapeutic targets, metabolizing enzymes and transporters of given drug molecules in order to understand its intricate therapeutic and pharmacokinetic profile.

Mohali Sub-District (S. A. S Nagar), Punjab, India

Master’s Research Project: Off-targets of CYP1A1 inducers were identified by integrating methods like structural bioinformatics, molecular docking, molecular dynamics simulation and pathway analysis.

Doctor Of Philosophy (Ph.D.), Pharmacoinformatics, A

Project: A computational tool was developed based on Proteochemometric (PCM), which can predict interaction profile of given chemical.

M.S. (Pharma), Pharmacoinformatics, 8.36 Cgpa

Project: Off-targets of CYP1A1 inducers were identified by integrating various methods ranging from structural bioinformatics like binding.

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, 66.25 %

Courses: Medicinal Chemistry, Pharmaceutical Analysis, Pharmacology, Human Anatomy and Physiology, Pathology, Biochemistry, Microbiology.

Higher Secondary Education, Science