Clinical Research Analysis
Nirupma Sahjeta
Gurugram
Summary
Accomplished pharmaceutical professional with 8.9 years of extensive experience spanning research and analysis, client support, syndicate research, competitive intelligence, and secondary research across diverse therapeutic domains. Demonstrated track record of delivering strategic support to enhance decision-making processes. Eager to integrate my expertise into a dynamic team environment to drive collective success.
Overview
9
9
years of professional experience
Work History
Assistant Manager
WNS Global Services Pvt. Ltd.
09.2019 - Current
- Clinical Trial assessment and Data review, provided clinical and scientific support to stakeholders.
- Updating adverse drug events in periodic safety report such as PPRER, PSUR etc.
- Proficient in using public and proprietary databases such as US FDA, EMEA, Clinical trial.gov,Trialtrove, etc. and well versed with ICH GCP guidelines.
- Analyzed data to uncover insights and identify key opportunities to inform strategic decisions.
- Collaborated with cross-functional teams to develop and implement market research strategies.
- Coordination with Internal and external stakeholders (respondents and agencies) to ensure smooth execution and delivery of projects in high quality.
- Created and managed database information as well as designed dashboards based on provided data from suppliers; maintained reports in the required MS Office format.
- Have experience in using data from clinical trials and scientific literature databases (PubMed, Google Scholar, ProQuest, Embase) to generate solutions for client's key R&D requirements.
- Data analysis and extraction from different databases and populated into the required MS Office format.
- Technical expertise in handling projects based on data analysis of Cortellis, Pharmaproject, Proquest, GNPD Mintel, etc
- Data extraction, analysis, and representation of information and insights from secondary research across pharma and consumer healthcare. Expertise in company profiling, drug profiling, clinical trial pull, news updates, annual reports, SEC filings, corporate events, etc.
- Actively conducted secondary research for opportunity assessment, market landscape, pipeline landscape and competitive intelligence for client-specific projects.
- Conducted thorough secondary research to assess opportunities, analyze market landscape, and gather competitive intelligence for client-tailored projects.
R&D Officer
Reckitt Benckiser Healthcare India Pvt. Ltd.
09.2016 - 08.2019
- Formulated Ointments, creams, and gels, and conducted pilot scale-up and method development/transfer.
- Led OOS/OOT investigations and handling of deviations on Track-wise Application.
- Managed stability testing, inventory, and shelf-life prediction.
- Team Lead for stability Management, Stability Inventory, and Tracker Management.
- Prepared SOPs and Specifications for US FDA/MHRA audits and supported US FDA and MHRA mock and real-time audits in the organization.
- R&D (A connection of formulation, analytical and Quality assurance, and regulatory affairs).
- Scheduling and performing stability testing and comparative testing on various healthcare products and shelf-life prediction of products in line with stability results.
Education
Master of Science in Pharmacy - Biotechnology
National Institute of Pharmaceutical Education and Research (NIPER)
MOHALI, PUNJAB06.2015
Bachelor of Pharmacy - undefined
Himachal Pradesh University
SOLAN, HIMACHAL06.2013
Skills
- Project Management
- Clinical Research
- Stakeholder Coordination
- Cross-functional Collaboration
- Technical Data Analysis
- Regulatory Databases
- Database Management & Dashboard Design
- MS Office (Excel, Word, PowerPoint, Teams)
- Data Extraction & Analysis
- Analytical Insight Generation
- Competitive Intelligence
- Secondary Research
- Pipeline Landscape
Nirupma Sahjeta
Software
Database Proficiency
Product Profiling
Competitive Intelligence
Competitive Landscape
Pipeline Landscape
Secondary Research
Interests
- Communication
- Flexible/Adaptable
- Learning Agility
- People skills
- Proactive
- Team Oriented
- Team Working
Timeline
Assistant Manager
WNS Global Services Pvt. Ltd.
09.2019 - Current
R&D Officer
Reckitt Benckiser Healthcare India Pvt. Ltd.
09.2016 - 08.2019
Bachelor of Pharmacy - undefined
Himachal Pradesh University
Master of Science in Pharmacy - Biotechnology
National Institute of Pharmaceutical Education and Research (NIPER)
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