Kalyani Varge
Nagpur (https://www.linkedin.com/in/kalyani-varge-07209b20b)
Summary
Medical Writer with almost 2 years of experience in Clinical Study Report (CSR) patient narratives across multiple therapeutic areas such as Oncology, Neurology (Multiple Sclerosis), Gastroenterology in manual as well as programmed narratives. Expertise in leading narrative development, QC review, and managing document lifecycles in compliance with ICH guidelines. Strong in client communication, cross-functional collaboration, and delivering accurate, high-quality documents within timelines.
Overview
3
3
years of professional experience
7
7
years of post-secondary education
Work History
Associate Medical Writer
IQVIA
Pune
06.2025 - Current
- Served as Lead Narrative Writer for sponsors across multiple therapeutic areas such as Oncology, Neurology (Multiple sclerosis) and Immune thrombocytopenia, managing end-to-end delivery of CSR patient narratives
- Drafted, QC reviewed, and finalized CSR patient narratives including addressal of sponsor comments, incorporating revisions, and preparing final deliverables ensuring accuracy and completeness
- Interacted directly with clients to ensure all documents complied with sponsor-specific writing guides
- Communicated effectively with oversight managers regarding project scope, timelines, and resource planning
- Performed eTMF filing activities and maintained Internal Signature page for ensuring proper documentation and audit readiness
- Mentored new writers on end-to-end narrative development, conducted sessions and huddles to allign team with study specifications
Medical Writing Trainee
IQVIA
Thane
06.2024 - 06.2025
- Authored and performed QC review of CSR patient narratives
- Co-leading activities to support lead narrative writer for timely delivery
- Ensured strict adherence to SOPs and regulatory guidelines (ICH E3 and E6), timely completion of trainings
- Detailed understanding of narrative writing procedure
- Received Spotlight award for quality of Narratives
Clinical Research Coordinator
AIIMS
Nagpur
07.2023 - 10.2023
- Managed patient recruitment and informed consent processes, improving participant engagement, retention, and study compliance.
- Coordinated clinical trial activities, ensuring strict adherence to Study protocols.
- Maintained accurate and up-to-date documentation of study-related data, source records, EDC, Narrative writing.
- Monitored participant progress and reported adverse events (AEs/SAEs) promptly to investigators and regulatory authorities.
- Maintained effective communication with investigators, study staff, sponsors, vendors, IRB/EC personnel, and other stakeholders throughout the trial lifecycle to support smooth study operations and compliance.
Education
Masters in Pharmacy -
Rashtrasant Tukdoji Maharaj Nagpur University
Nagpur, India 12.2021 - 07.2023
Bachelor of Pharmacy -
Rashtrasant Tukdoji Maharaj Nagpur University
Nagpur, India 08.2018 - 09.2021
Diploma in Pharmacy -
Shri. K. R. Pandav Institute of Pharmacy
Nagpur, India 08.2016 - 06.2018
Skills
- Good understanding of CSR patient narratives writing
- Excellent written and verbal English and attention to detail
- Strong organizational and multitasking abilities
- Proven leadership and mentoring skills
- Effective client-facing communication and comment resolution
- Ability to work independently with minimal supervision
Languages
Hindi
First Language
English
Upper Intermediate (B2)
B2
Timeline
Associate Medical Writer
IQVIA
06.2025 - Current
Medical Writing Trainee
IQVIA
06.2024 - 06.2025
Clinical Research Coordinator
AIIMS
07.2023 - 10.2023
Masters in Pharmacy -
Rashtrasant Tukdoji Maharaj Nagpur University
12.2021 - 07.2023
Bachelor of Pharmacy -
Rashtrasant Tukdoji Maharaj Nagpur University
08.2018 - 09.2021
Diploma in Pharmacy -
Shri. K. R. Pandav Institute of Pharmacy
08.2016 - 06.2018