Subhajit Samanta work email
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Subhajit Samanta personal email
Experience in LSMV, ARGUS and ArisG safety data base, case triaging, data entry, MedDRA coding of events, causality assessment& labeling (CCDS, SmPC, USPI, and IB), narrative writing, case routing, case lock, Literature screening and validation for pharmacovigilance. I can take responsibility for tasks and react to changing priorities. Have a good interpersonal skill and relevant synopsis of medical text and data, and the ability to write unambiguous medical text independently. I am proficient in windows and application software. I want to contribute my skills and hard working ability to healthcare solutions.
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Operations SpecialistIqviaBengaluru, Ka, In -
Operations SpecialistIqvia Feb 2021 - PresentBengaluru, Karnataka, India• Reviewing and tracking non-serious as well as serious documents in intake, receipt, and triage (IRT) environment for all suspect as well as partner products and all case types (ArisG).• Handling clinical trial cases (ex: trial for COVID-19, Rheumatoid Arthritis, Bronchopulmonary Dysplasia in newborn baby).• Performing unblinding for Clinical Trial cases.• Communicating with adverse event (AE) supplier regarding queries in the information sent to IRT.• Perform data entry of serious and non-serious adverse events in safety database, coding relevant medical terminology, writing descript serious and non-serious narratives, generating queries pertinent to the case in case journal list of safety database.• Perform follow up activity of serious and non-serious cases as per client timeline.• Performing quality review activity for all type of cases.• Train and mentor new team members as per requirements of the project.• Identify and resolves issues within the project team. -
Senior Drug Safety AssociateBioclinica Jan 2019 - Feb 2021Mysore ,Karnataka• literature reviewer for abstracts, citations, and full publications (FP).• Abstracts, citations and full publications (FP) evaluation to determinevalidity for entry into data base, identification of event terms,determine causality, assess seriousness, and assess validity as per client.• Oder full publication or retrieval of full publications for any case created from an abstract.• Performed as quality reviewer for citation/ FP received from initial reviewer and confirms the validity for entry into the data base.• Responsible for completion of day-to-day work and process flows within the agreed service levels (SLAs).• Maintaining the data as per the customer guidelines.• Co-ordination with team on problem solving initiatives. -
Junior Data Analyst ( Pharmacovigilance { Drug Safety Associate} )Cognizant Feb 2018 - Jan 2019India• Manage the receipt and processing of all adverse event reports (Exp.: Spontaneous case, Literature case, Post Authorization Safety Study (PASS), Post marketing surveillance, Clinical trial case), perform initial checks, search database to prevent duplicate entries (ARGUS).• Each reported adverse event within a case is evaluated for potential upgrade for seriousness.• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from the source documents with emphasis on timeliness and quality.• Co-ordination with team on problem solving initiatives.• Maintaining the data as per the customer guidelines. -
Trainee Junior Data Analyst ( Pharmacovigilance { Drug Safety Associate} )Cognizant India Pvt. Ltd. Jan 2017 - Jan 2018Kolkata, West Bengal• Manage the receipt and processing of all adverse event reports (Exp.: Spontaneous case, Literature case, Post Authorization Safety Study (PASS), Post marketing surveillance), perform initial checks, search database to prevent duplicate entries (ARGUS).• Coding of company suspect drug with company product dictionary (CPD) and review coding of other company suspect drugs, concomitant, past and treatment drugs using WHO DD.• Coding of following fields using the most appropriate lower-level term (LLT) from MedDRA, like medical history, reported adverse event, lab data and procedures.• Determine expectedness and causality.• Write and review case narrative.
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Formulation Development TraineeZydus Cadila Research Center Oct 2015 - Mar 2016Mumbai, ThaneProcurement of innovator sample, Develop the strategy for development of generic Corticosteroid Cream , Ointment, Anti acne gel, Corticosteroid lotion, hormonal solution,Develop the QBD.
Subhajit Samanta Skills
Subhajit Samanta Education Details
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Gupta College Of Technological SciencesPharmaceutical Sciences -
Belda Gangadhar AcademyPharmaceutical Sciences
Frequently Asked Questions about Subhajit Samanta
What company does Subhajit Samanta work for?
Subhajit Samanta works for Iqvia
What is Subhajit Samanta's role at the current company?
Subhajit Samanta's current role is Operations Specialist.
What is Subhajit Samanta's email address?
Subhajit Samanta's email address is sa****@****ahoo.in
What schools did Subhajit Samanta attend?
Subhajit Samanta attended Gupta College Of Technological Sciences, Belda Gangadhar Academy.
What skills is Subhajit Samanta known for?
Subhajit Samanta has skills like Pharmacovigilance, Formulation Development, Product Development, Clinical Data Management, Gmp, Qbd, Ich Guidelines, Generic Drug Development, New Drug Application, Anda, Dmf, Microsoft Excel.
Who are Subhajit Samanta's colleagues?
Subhajit Samanta's colleagues are Dr. Femi Ann Max, Wojciech Urbańczyk, Franchette Darlene Cruz, Cema Ouma Msiza, Irene Brusini, Cleo Garcia Bsn, Rn, Ocn, Judith Bolding.
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Subhajit Samanta
Senior Management Consultant At Pwc || Ex-Deloitte || Ex-Bofa|| Merit Scholar (Mba, B-Tech) || Cfa Level 1 ClearedDelhi, India3bankofamerica.com, imi.edu, gmail.com -
Subhajit Samanta
Senior Application Developer- Cloud Full Stack | Java | Aws | Microservices | Generative AiKolkata -
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1sipindustries.com
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