Nirupama Tiwari Email & Phone Number

Remote

Gurgaon, India

o Involved in Regulatory document preparation, dossier preparation for various countries globally for registration of agrochemical product as per their respective regulatory requirements.o Analysis of studies, research reports, toxicological reports, physical-chemical properties and various requirements as per country regulations.

Gurgaon, India

• In-depth knowledge of the structural and content requirements of regulatory documents, such as Investigator’s Brochures, Clinical Trial Protocols, Clinical Trial Reports, narratives, Common Technical Document (CTD) summaries etc. and publication documents like abstracts, posters, slide decks, etc.• Worked on building learning modules for • Worked on research proposal review and prescribing information.• Performed medical transcription for pharma clients.• Operational knowledge of drug development, clinical trial and other practices.• Familiarity with American Medical Association (AMA) guidelines, Good Publication Practice (GPP) and various referencing style like vancouver style of referencing• Good understanding of common statistical methods used in clinical trials and interpretation of their results.• Prepared clinical regulatory documents following predefined guidelines in a team environment. • Developed client-specific medical content. • Ensured accuracy and consistency of all documents compliant with company rules. • Reviewed clinical trial protocols, case report forms, and statistical analysis plans.• Creates documents consistent with customers' internal guidelines as well as regulatory agencies• Conducts comprehensive literature searches using search engines like Pubmed and EMBASE.• Ensures that safety information, including adverse events, are reflected along with efficacy in medical documents

Delhi Area, India

• Well experienced on various data management skills like merging, handling missing values, reading raw data files, Creating data structures, Handling Programming Errors, Assessing and managing data, Appending, Preparing Derived Datasets, Concatenating, merging of SAS datasets and reading external data files. • Created slide deck and social media content• Produced reports which were generated based on requirements like weekly and monthly-customized reports by using Proc tabulate, Proc report.

Bangalore

Responsibilities include:• Produced reports which were generated based on requirements like weekly and monthly-customized reports by using PROC TABULATE, PROC REPORT.• Creation of datasets from source files using import techniques and data step.• Running and analyzing data and creating reports to meet the requirements• Modification of existing datasets using set, merge, sort, update and conditional statements.• Good command in producing reports employing various SAS procedures.• Worked on ODS extensively to generate reports in HTML, RTF, PDF and EXCEL reports.• Develop project specific procedures for loading external data and/or transferring internal data and verifying the process. Ensuring client specifications for data transfers are met and be responsible for receiving or sending internal and external data.• Extensively used SAS procedures such as PRINT, REPORT, TABULATE, FREQ, MEANS, SUMMARY, TRANSPOSE for producing ad-hoc and customized reports and external files• Analyzed data and generate tables, listings and figures.• Testing Categorical Data with PROC FREQ, Producing Statistics with PROC MEANS.• Used various SAS functions like character functions, numeric functions and date functions• Performing UAT on IVRS and IWRS platforms as a functional tester and a test coordinator. • Involved in requirement analysis, test design, test execution, test reporting and defect lifecycle, gained knowledge on the testing tool HPQC.• Expertise working on test estimations create/ review work orders/ change orders, weekly status reporting, monthly productivity metrics. • Train new team members on manuals, SOP’s, validation and testing of IXRS systems, DiaryPro and SitePro.

Bangalore, India

Responsibilites include:Working on eCRF(Inform, phase Forward, OC RDC), Handling source documentation,patient activity,documentation for Ethics Committee, handling trials: bacterial vaginosis phase III trial, Iron defeciency Phase III trial, Deep Vein thrombosis, Psoriasis phase II, Asthma trial phase III, POISE 2 trial.

Master Of Science (M.Sc.), Biotechnology

Activities and Societies: o Attended "National Conference on Recent Trends & Environment Toxicology" held at ICEG College, Jaipur. o.

Bachelor Of Science (B.Sc.), Biotechnology, 1St

Graduated from Holkar science college with a degree in B.Sc.biotechnology

Education record