Neharika Sharma

Associate Director @GSK

Philadelphia, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2023 — Present

Associate Director @GSK

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US

EDUCATION

2009 — 2010

IBAB, Bangalore

Post-Graduation Diploma in Bioinformatics (PGDB)

2007 — 2009

DAV College, Jalandhar (Punjab)

B.Sc. Bioinformatics and Advance Diploma in Biotechnology

SKILLS

Pharmaceutical IndustrySqlRegulatory SubmissionsClinical ResearchValidationCdisc StandardsClinical TrialsScientific AnalysisResearch and Development (R&D)SasVendor ManagementOncologyProtocol

ABOUT NEHARIKA SHARMA

Synopsis:Working in R&D sector of GlaxoSmithKline Pharmaceuticals and formerly Novartis HealthCare with a total experience of around 8 years. Expertise in Clinical data analysis through SAS and proficient in end-to-end support for reporting of drugs to various regulatory bodies. Exposed to a wide range of therapeutics like Oncology, Respiratory, Dermal and neurosciences. Leading and managing projects exhibiting strategic agility, organizational skills and enriching associations across seas.Technical Strengths:CDISC Reporting (SDTM and ADaM structures)SAS BASE including SAS Procedures, PROC SQLSAS MACROSTIBCO Spotfire Clinical Graphics (TSCG)Acquaintance to various programming languages: Perl, C, C++, Java (swings), SQL, WebTechnology (HTML, dynamic Web-Pages)Specialties:Expertise in Oncology Reporting conventionsAcross functional Clinical Domain process knowledgeVendor ManagementClient HandlingProject ManagementArea of Expertise: Exposure of handling Post Marketing Safety and Tolerability objectives for Phase and Phase IV studies in various therapeutics like Chronic Spontaneous Urticaria (CSU), Psoriatic Arthritis, Breast Cancer, Multiple Sclerosis. Scientific Analytic Requests from various regulatory bodies for major blockbuster drugs.Exposed to various phases of Clinical trial (Phase I-IV) with different indications like Advanced Solid Tumors, Brain metastasized Non-Small Cell Lung Cancer, Renal impaired function with malignant solid tumors, Leukemia, COPD, Epilepsy, Hyperhidrosis, Acne Vulgaris etc. Worked on FDA/EMA/MHLW/CFDA submissions with various different study designs and study specific endpoints.Extensively involved in recruitment, resourcing and financial management.

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Neharika Sharma — Associate Director at GSK in Philadelphia, PA, US | Unifers