Dr.Suchita Pandey
Medical Writer
Summary
Personable and articulate communicator with keen eye for detail and knack for translating complex medical information into clear, concise writing. Possesses solid foundation in medical terminology and scientific research, coupled with strong technical writing skills. Dedicated to producing high-quality, impactful content that enhances understanding and promotes better health outcomes.
Overview
5
5
years of professional experience
2023
2023
years of post-secondary education
Work History
Medical Writer
Parexel
04.2023 - Current
- Managed end-to-end preparation and submission of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs), ensuring adherence to global regulatory standards
- Prepared narratives for Clinical Study Reports (CSRs) to meet client and regulatory authority requirements, ensuring medical accuracy and data consistency
- Conducted signal detection and evaluation using client databases, literature, and regulatory authority websites to identify potential safety concerns
- Collaborated with safety science teams to manage the full lifecycle of signal detection, including tracking, assessment, and communication of safety signals
- Generated and analyzed Line Listings for regulatory submissions, identifying and resolving discrepancies
- Developed and updated Risk Management Plans (RMPs) and Health Hazard Evaluations (HHEs), contributing to the safety and regulatory strategies of client products
- Conducted systematic literature reviews to gather background epidemiological data for inclusion in safety reports and regulatory submissions
- Ensured all aggregate reports and clinical study narratives met stringent quality control standards prior to submission to internal teams or health authorities
- Led and coordinated project meetings, including agenda preparation, drafting minutes, and tracking action items to ensure timely project execution
Medical Writer / Content Writer
Freelance-writers
01.2020 - 03.2023
- Created scientific content for academic and organizational needs, including articles, summaries, and reviews.
- Ensured clarity and accuracy in documents tailored to specific audiences.
Pharm.D Intern
Shri Mahant Indiresh Hospital
08.2022 - 01.2023
- Conducted a research study titled “Evaluation of Risk Factors in Acute Exacerbation of COPD at a Tertiary Care Hospital.”
- Provided clinical insights and collaborated on patient management strategies.
Education
Pharm. D -
Shri Guru Ram Rai University
HSC - undefined
K.L International School
SSC - undefined
K.L International School
Skills
- Ability to Work Under Pressure
- Time Management
- Communication
- Microsoft Office
- Project Management
- Problem Solving
- Team Working
- Scientific presentations
- Publication planning
- Content strategy
Accomplishments
- Secretary, Journal Club
- Appointed as the General Secretary of the College's Student Council
- Cultural Secretary of my school during my intermediate
- Awarded as best anchor during my college and school tenure multiple times
Extra-curricular activities
Volunteered and managed a Health Camp organized by the College & Hospital of study. Participated in the administration regulation and collaboration of Department of Clinical Pharmacy, SMIH. Content writing, scientific writing for academics, and other organizations. Attended Conferences & webinars related to Clinical Pharmacy.
Coursesworkshops
- Medical writing for Healthcare Professionals
- Clinical Operations and Risk Based Monitoring Industry Perspectives, JSS College of Pharmacy
- Skill Development Programme on Pharmacovigilance for Medical Products, NCC-Pharmacovigilance Programme of India
Timeline
Medical Writer
Parexel
04.2023 - Current
Pharm.D Intern
Shri Mahant Indiresh Hospital
08.2022 - 01.2023
Medical Writer / Content Writer
Freelance-writers
01.2020 - 03.2023
HSC - undefined
K.L International School
SSC - undefined
K.L International School
Pharm. D -
Shri Guru Ram Rai University
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