TAANYA SHARMA
JAMMU
Summary
A seasoned medical writer with over 2 years of experience crafting clear, medically cohesive and accurate client products in clinical trials, according to client guidelines and SOPs, and applicable regulatory requirements.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Medical Writer
Continuum India LLP
Chandigarh
04.2022 - Current
- Preparation of CSRs
- Primary author of patient safety narratives for CSRs
- Assessing, extracting, and summarizing data from Clinical and Safety Databases, including other provided source outputs
- Performed peer review
- Template development
- Trained and mentored new team members
- Conducted trainings for team
Education
Master of Science - Microbial Biotechnology
Panjab University
Chandigarh 07-2021
Skills
- International drug safety regulations including ICH guidelines, FDA guidelines, EMA, New EU PV legislation, and CIOMS
- GVP, GCP, and CTD
- MedDRA
- Aggregate reports (PBRERs, PSURs, DSURs, PADERs, ACO, IPSRs, and DSRs)
- Literature triage for Aggregate reporting
- Drug development process
- Clinical study protocols, IBs, SAPs, and TLFs
- Microsoft Word, Microsoft Excel and Microsoft PowerPoint
- EndNote
- Medical terminologies
- Proofreading
Certification
- US FDA | Small Business and Industry Assistance Integrated-Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes (Mar 2024)
- US FDA | CDER | Small Business and Industry Assistance- FDA Clinical Investigator Training Course (Dec 2023)
- 30 days hands-on training on microbiological techniques, Department of Microbiology, Panjab University, 2018
Languages
Hindi
First Language
English
Proficient (C2)
C2
Personal attributes
• Confident
• Motivated
• Determined
• Diligent
• Data interpretation and evaluation
• Attention to detail
• Typing and transcription accuracy
• Good communication skills
• Collaborative
• Resilient
References
References available upon request.
Timeline
Medical Writer
Continuum India LLP
04.2022 - Current
Master of Science - Microbial Biotechnology
Panjab University
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