Dr. Shashank M Jogur
Address: Vijayanagar, Bangalore Karnataka – 560040
Professional Summary
Detail-oriented and highly motivated Pharm.D graduate with hands-on exposure to
pharmacovigilance and safety data management, complemented by a strong understanding of
document management best practices. Skilled in collecting, tracking, and processing adverse events
(AEs), writing narratives, and MedDRA coding. Knowledgeable in ICH-GCP guidelines and safety
regulations including FDA and EMA. Seeking to leverage strong organizational, analytical, and
communication skills to contribute to a safety operations team, specifically in a dynamic document
management role focused on maintaining compliance and data accuracy within eTMF systems.
Core Competencies
- Document Management and Archiving (Paper and Electronic)
- Electronic Trial Master File (eTMF) Maintenance and Quality Control
- Regulatory Compliance (ICH-GCP, FDA, EMA)
- Adverse Event (AE) Data Collection and Tracking
- Case Processing and Database Entry
- Safety Narrative Writing and MedDRA Coding
- Data Entry and Quality Checks
- Strong Attention to Detail and Time Management
- Effective Verbal and Written Communication
- Proficient in Microsoft Office (Word, Excel, PowerPoint) and Web-Based Tools
- Literature Search Tools (Pubmed training exposure)
- Scientific writing
Education
Doctor of Pharmacy (Pharm.D) | BLDEAS SSM College of Pharmacy, Vijayapura
- Completed coursework in pharmacology, toxicology, and clinical research
Certifications & Training
- Good Clinical Practice (GCP) Certification
- Certified in Medical Terminology (CMT)
- Basic Life Support (BLS) – Cardiology Focus
- Certificate in Clinical Research – Clindus Academy Solutions
Research and Internship Experience
- Pharm.D Internship | BLDEAs Hospital, Vijayapura
- Assisted in clinical trial-related tasks including AE tracking and reporting
- Supported safety documentation and IRB submission preparation
- Contributed to data entry and quality checks to ensure regulatory compliance
- Interpreted lab reports and helped review patient medication charts for ADRs
- Gained practical exposure to maintaining accurate and complete clinical trial records
Technical Proficiency
- Document Management: Electronic Trial Master File (eTMF) applications (training exposure), Paper Document Collection, Indexing, Storage, Retrieval, Archiving Databases
- Software: Microsoft Word, Excel, PowerPoint
- Coding: MedDRA Coding (training exposure)
- Databases/Tools: Pubmed (training exposure)
Publications
- Cyclosporine-Induced Hypertrichosis and Hypokalemia in an Infant: A Case Report Journal of Hospital Pharmacy (JOHP), 2025-1
Project
- Assessment of Medication Adherence in Cardiovascular Disease Patients Conducted at BLDEA’s Hospital under the guidance of Dr. Sunanda Nandikol
Skills
Document Management, eTMF, Regulatory Compliance, Adverse Event Tracking, Data Entry, Safety Narrative Writing, MedDRA Coding, Time Management, Communication, Microsoft Office, Literature Search, Scientific Writing
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Cover Letter:
Dear HR/ Recruiter
I am Shashank Jogur, Pharm D graduate writing this to show interest in Clinical research associate job as posted recently
My skills and experience allign to the job description and my clinical trial knowledge would be fit for this job role
Kindly consider me for this role and please review my CV
Thank you
Shashank M Jogur
interested