ASHOK YEKASRI
Vijayawada
Summary
Medical Writer with 9+ years of experience in pharmacovigilance, clinical safety, and regulatory documentation. Expertise in preparing safety narratives, literature reviews, and regulatory-compliant documents aligned with ICH, GCP, FDA, EMA, and Health Canada guidelines. Proven ability to transform complex clinical and safety data into clear, concise, and submission-ready medical content.
Overview
11
11
years of professional experience
Work History
Drug Safety Associate
Cencora
06.2024 - 02.2026
- Authored and reviewed clinical safety narratives for adverse event reports
- Conducted literature screening and summarized scientific data for safety signals
- Ensured regulatory compliance of safety reports per SOPs and global guidelines
- Performed QC of ICSRs ensuring accuracy, completeness, and consistency
- Prepared reconciliation reports and supported regulatory documentation
- Drafted follow-up queries for missing or unclear safety information
- Managed adverse event reports ensuring compliance with regulatory standards.
- Conducted thorough product safety evaluations utilizing industry-specific databases.
Pharmacovigilance Coordinator
Shoppers Drug Mart
03.2023 - 06.2024
- Developed source documentation for adverse events and product complaints
- Supported preparation of safety reports aligned with regulatory standards
- Conducted data validation, reconciliation, and compliance tracking
- Contributed to CAPA documentation and root cause analysis
- Documented meeting minutes and workflow summaries
Personal Support Worker
Home Instead Senior Care Home
08.2021 - 11.2022
- Assisted clients with daily living activities to enhance comfort and independence.
- Developed personalized care plans based on individual client needs and preferences.
- Coordinated transportation for medical appointments, ensuring timely access to healthcare services.
- Monitored client health status, reporting changes to healthcare professionals promptly.
Senior Safety Science Specialist
Covance
09.2018 - 01.2021
- Authored detailed safety narratives and performed clinical case assessments
- Conducted literature review and validation for regulatory reporting
- Interpreted safety data for aggregate reporting and signal detection
- Performed QC of ICSRs and ensured adherence to regulatory standards
- Supported audit readiness and inspection documentation
Senior Drug Safety Associate
Bioclinica
08.2016 - 05.2018
- Reviewed and summarized medical literature (oncology, renal)
- Assisted in SOP development and regulatory documentation updates
- Performed clinical data entry, coding, and quality review
- Supported audit processes and compliance documentation
- Trained team members on safety documentation standards
Global Safety & PV Assistant I
Syneos Health
03.2015 - 07.2016
- Processed adverse event cases and contributed to safety documentation
- Performed MedDRA coding and data validation
- Assisted with reconciliation and compliance reporting
Education
Diploma in Operations Management
Alison Institute
India05-2026
PG Diploma - Healthcare Administration & Management
Conestoga Autonomous
Canada01.2022
PG Diploma - Pharmacovigilance
JSS University
India01.2014
PG Diploma - Clinical Pharmacology
JSS University
India01.2014
PharmD - undefined
JSS University
India01.2014
B.Pharm - undefined
JNTU Kakinada
India01.2011
Skills
- Medical writing
- ICSR and narrative writing
- Preparation of PSUR and DSUR
- Clinical safety data analysis
- Literature Review (PubMed, Embase)
- ICH-GCP, FDA, EMA, Health Canada Guidelines
- MedDRA Coding & WHO-DD
- Argus Safety Database
LANGUAGES
English – Fluent
French – Intermediate
KEYWORDS FOR ATS
Medical Writing, Clinical Documentation, Pharmacovigilance, Safety Narratives, PSUR, DSUR, Regulatory Writing, ICH Guidelines, Literature Review, Signal Detection, MedDRA, Argus Safety, QC Review, CAPA
Timeline
Drug Safety Associate
Cencora
06.2024 - 02.2026
Pharmacovigilance Coordinator
Shoppers Drug Mart
03.2023 - 06.2024
Personal Support Worker
Home Instead Senior Care Home
08.2021 - 11.2022
Senior Safety Science Specialist
Covance
09.2018 - 01.2021
Senior Drug Safety Associate
Bioclinica
08.2016 - 05.2018
Global Safety & PV Assistant I
Syneos Health
03.2015 - 07.2016
PG Diploma - Pharmacovigilance
JSS University
PG Diploma - Clinical Pharmacology
JSS University
PharmD - undefined
JSS University
B.Pharm - undefined
JNTU Kakinada
Diploma in Operations Management
Alison Institute
PG Diploma - Healthcare Administration & Management
Conestoga Autonomous