Anjali Singh
Greater Noida
Summary
Detail-oriented Medical Writer recognized for high productivity and efficiency in completing tasks. Specialized in authoring and reviewing clinical and regulatory documents, ensuring clarity and compliance with industry standards. Strong time management, critical thinking, and collaboration skills enhance project outcomes. Committed to excellence in drug safety documentation and contributing expertise to organizational success.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Medical Writer/PV Specialist
Continuum India LLP
Chandigarh
04.2025 - Current
- Expertise in writing narratives for Clinical Study Reports (CSR), which included: Preparing clear and medically sound narratives based on the clinical and safety database outputs; conducting quality checks to ensure compliance with client SOPs and regulatory standards; concatenating narratives for CSR integration; providing training and mentoring to medical writers in narrative development
- Performing quality reviews of a wide range of regulatory documents, including CSRs, Investigator's brochures (IBs), clinical trial protocols, CTD modules, patient safety narratives, and responses to regulatory authority queries
- Processing of Individual Case Safety Reports (ICSRs) and related processes, including acceptance, data entry and quality check in client database in accordance with applicable client and regulatory requirements; mentoring new team members in ICSR related process
- Hands-on experience of working on clinical and safety databases such as RAVE and PV systems/tools such as SharePoint, Argus Safety, and AB-cube SafetyEasy
Medical Writer/PV Analyst
Continuum India LLP
Chandigarh
04.2023 - 03.2025
- Prepared clear, medically cohesive, and accurate patient safety/CSR narratives based on clinical and safety database outputs, adhering to the client's conventions, guidelines, and SOPs
- Conducted quality checks on CSR narratives to ensure compliance with client SOPs and regulatory requirements, while maintaining high-quality standards
- Developed narrative templates in accordance with the client's conventions and guidelines
- Provided training and mentoring to medical writers and team members on clinical databases, electronic data capture systems, and CSR narrative writing activities
- Performed quality reviews of a wide range of regulatory documents, including CSRs, IBs, clinical trial protocols, and CTD modules
- Managed activities related to ICSR processing in client database in accordance with applicable client and regulatory requirements
Medical Writer/PV Scientist
Continuum India LLP
Chandigarh
05.2021 - 03.2023
- Authored precise and medically sound CSR narratives aligned with client and regulatory standards
- Conducted quality checks on narratives to ensure high quality of work
- Maintained an in-depth knowledge of international drug safety regulations, including ICH, FDA, New EU PV legislation, etc.
- Maintained an understanding of the drug development process
Management Trainee
Quality Council of India
New Delhi
08.2019 - 01.2021
- Worked in the Secretary General's cell along with cross-functional teams on classified projects of the Government of India
- Strategic communications and project implementation with external as well as internal stakeholders
- Conduct primary and secondary research analyses to leverage the results to drive decision-making and survey development
Education
Master of Pharmacy - Pharmaceutical Quality Assurance
Jamia Hamdard
New Delhi, India07-2019
Bachelor of Pharmacy - Pharmacy
Rajasthan University of Health Sciences
Jaipur, India07-2017
Intermediate Certificate - CBSE
Kendriya Vidyalaya No 1
Jalandhar, India06-2013
High School - CBSE
Kendriya Vidyalaya Koliwada
Mumbai, India06-2011
Skills
- Computer Proficiency (MS Word/ MS Excel/ MS PowerPoint/ MS Teams)
- Data interpretation and evaluation
- Narrative writing and attention to detail
- Typing and transcription accuracy
- Use of AI tools (ChatGPT/ Microsoft Copilot/Perplexity)
- Training and mentoring
- Strong oral and written communication
- Leadership and team collaboration
- Time management and adaptive learning
Accomplishments
NIPER JCC 2019 - Qualified (PhD in Medical Sciences)
GPAT 2017 - Qualified
Certification
- NPTEL - Health Research Fundamentals (Mar 2021) - 71%
- Harappa - Embracing Change
Timeline
Medical Writer/PV Specialist
Continuum India LLP
04.2025 - Current
Medical Writer/PV Analyst
Continuum India LLP
04.2023 - 03.2025
Medical Writer/PV Scientist
Continuum India LLP
05.2021 - 03.2023
Management Trainee
Quality Council of India
08.2019 - 01.2021
Master of Pharmacy - Pharmaceutical Quality Assurance
Jamia Hamdard
Bachelor of Pharmacy - Pharmacy
Rajasthan University of Health Sciences
Intermediate Certificate - CBSE
Kendriya Vidyalaya No 1
High School - CBSE
Kendriya Vidyalaya Koliwada
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