Santosh Kumar Lenka Email and Phone Number

Serving for a tough client "Novartis Health Care India Pvt.Ltd" as Pharmacovigilance Data Manager in Argus Safety Database (Pharmacovigilance Information System)Responsibilities:• Understand and translate data retrieval need into query request, create query criteria, retrieve data from the safety database and provide the results to DS&E colleagues or external line functions.• Generate regulatory reports, standard reports, tabulations, graphs and retrievals in preparation for… Show more Serving for a tough client "Novartis Health Care India Pvt.Ltd" as Pharmacovigilance Data Manager in Argus Safety Database (Pharmacovigilance Information System)Responsibilities:• Understand and translate data retrieval need into query request, create query criteria, retrieve data from the safety database and provide the results to DS&E colleagues or external line functions.• Generate regulatory reports, standard reports, tabulations, graphs and retrievals in preparation for regulatory submission.• Implementation and development of templates for different periodic reports and writing SQL and SAS logic in generating Ad-hoc searches/ Special searches/ Periodic Searches.• Providing high quality and timely Data Management support for regulatory submissions by providing data, reports as required with Quality & in time.• Create programs for tables, figures and listings for different submissions as per PVDM guidelines.• Documenting the requirements with different versions as per different releases. Show less

Serving to PROJECT: Argus Safety Database (Pharmacovigilance Information System) as Assistant Pharmacovigilance Data Manager(Intern)

Clinical Research and Data managementProject Description as Lead:• Type 1 Diabetes Genetics Consortium project sponsored by NIH & NIDDK.• Changing Diabetes in children (CDiC) by Novo Nordisk Education Foundation.• Effective Management of Diabetic foot by WDF, Denmark.• Course Coordinator in International Student Exchange programme between Kanungo Institute of Diabetes Specialities (KIDS), India and Karolinska Institute (KI), Sweden• Stress and Metabolic Syndrome… Show more Clinical Research and Data managementProject Description as Lead:• Type 1 Diabetes Genetics Consortium project sponsored by NIH & NIDDK.• Changing Diabetes in children (CDiC) by Novo Nordisk Education Foundation.• Effective Management of Diabetic foot by WDF, Denmark.• Course Coordinator in International Student Exchange programme between Kanungo Institute of Diabetes Specialities (KIDS), India and Karolinska Institute (KI), Sweden• Stress and Metabolic Syndrome (SMS) in collaboration with NISER, Bhubaneswar.• Novo Nordisk Pvt Ltd sponsored projects: Phase III & Observational Study of Type 2 Diabetes.• Observational study of Type 2 Diabetes from Sanofi-Aventis.• Phase III study of T2DM of Sanofi-Aventis. Show less