5 Years of experiences in clinical field by analyzing & updating data form various tools and clinical sites such as Medidata rave, Pharmacovigilance, good exposure on aggregate reports PADER, PBRER, PSUR, DSUR, scientific writing and medical writing through literature survey, publications, research writing, daily news, conferences. Skilled in secondary research, analyzing & documenting pharma products (Semi-solids, Liquids) using varoius medical devices & instruments. Presentations, Newsletters, Market Research & consulting industry, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, and Time Management, Competitive Intelligence, Report Writing, data visualization, and Teamwork, project management, regulatory affairs, safety report presentations. Strong research professional with a Master's Degree focused in Pharmacology from PES college of pharmacy.
Hi, I’m
Ragini Singh
Gurgaon
Summary
Overview
5
years of professional experience
Work History
R1 RCM
Pharmacovigilance
01.2023 - 03.2024
Job overview
- Handled patient documents such as Safety data review, signal detection, by analyzing data regarding disease, adverse effect, side affect, therapeutic areas, exclusion and inclusion areas
- Preparation of Pharmacology report, Narratives, clinical summary of safety and efficacy
- Aggregate report formations such as PADER, PBRER, PSUR as per regulatory guidelines, medical affairs
- Medical writing, Clinical documents, protocol preparation, clinical study report
- ICD 10 code for disease, Using EPIC tool
- Seconday research, Web portal for providers
- Risk management works such as collection and analysis of data gathered from publically available sources and reports
- Handling and providing trainings to a team and upcoming members.
WNS Global Services
Clinical trial data analysis
09.2020 - 12.2022
Job overview
- Clinical trial data analysis with Medidata rave, Pharmacovigilance, ADE, ADR aggregate reports PADER, PBRER, PSUR, DSUR, maintenance of trials on daily basis, trial news, daily basis, trial conferences, medical & content writing and editing, Secondary research and market research, clinical trial registry task.
Group pharmaceuticals Ltd
QC Analyst
06.2017 - 08.2018
Job overview
- Quality analyzing and updating of semi-solids, liquids and solid products data and document(SOP,COA) maintenance, checking various parameters of products via different methods & instruments, wet lab analysis
- Researched and Finalized Report Topics for Syndicated Research Studies.
Education
PES college of PharmacyBangalore, Karnataka
M. Pharm from Pharmacology
09.2020
University Overview
Gupta College of Technological SciencesAsansol, West Bengal
B. Pharma
07.2017
University Overview
Skills
- Pharmacovigilance expertise
- Pharmacovigilance knowledge
- Pharmacovigilance Monitoring
- Pharmacovigilance Compliance
- Pharmacovigilance
- Pharmacovigilance Reporting
- Site monitoring
- Clinical trial management
- Standard Operating Procedures
- Adverse event reporting
- Protocol development
- Study coordination
- Case report form completion
- Site Selection
- Clinical Study Reports
- Clinical data review
- Investigational product handling
- Drug Safety Monitoring
- IRB and IEC Submissions
- Clinical Research Ethics
Expertiseanddatabases
Expertiseanddatabases
Secondary Research, Monitoring News and Commercials, Conference Coverage, Product and Drug Analysis, News Monitoring, SWOT Analysis, Competitive Landscaping, Medidata Rave, Argus, Pharma Project, Trial Trove, Refinitive Workplace, Inoreadaer, Evaluate Pharma, Bloomberg, DnB Brand sheet, Hoovers, Factiva, Zoom info, Clinical trial registries (US, EU, Canada, etc), Regulatory websites (US, TGA, FDA, EMA, Health Canada, etc)Achievements - Publications
Achievements - Publications
- Evaluation of antiurolithiatic activity of alcoholic extracts of Cayratia trifolia against experimentally induced renal calculi in rats, https://www.bjpmr.org/issue-5-september-october-2020/
- Childhood Urolithiasis- A review, https://wjpr.net/dashboard/abstract_id/14927
Personal Information
Personal Information
- Father's Name: Ram Singh
- Husband's Name: Brajesh Kumar
- Date of Birth: 01/06/1994
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Bengali
Advanced (C1)
Timeline
Pharmacovigilance
R1 RCM
01.2023 - 03.2024
Clinical trial data analysis
WNS Global Services
09.2020 - 12.2022
QC Analyst
Group pharmaceuticals Ltd
06.2017 - 08.2018
PES college of Pharmacy
M. Pharm from Pharmacology
Gupta College of Technological Sciences
B. Pharma