Dr. Gunasheela S
Mysore
Summary
Dentist currently working in PV, with more than 3 years of experience in clinical and post-marketed products in multiple therapeutic areas, including oncology and neurology. I have expertise in end-to-end case processing of ICSRs, MedDRA coding, WHODD, CDD, narative writing, query generation, compare and reconcile. Comitted, self-directed leader known for subject matter expertise and careful attention to detail.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Product Safety Specialist
Eisai
Nutley, New Jersy
08.2022 - 11.2024
- Triage, data entry and quality review of serious and non-serious adverse event reports from clinical trial, post marketing studies, spontaneous, literature, partner and regulatory authority cases.
- Complete data of ICSR into ArisG and LSMV.
- Review, compare and reconcile, process and document case related information.
- Used MedDRA for coding AEs and WHODD and CDD for medications.
- Query generation and follow-ups through emails and fax.
- Generated concise, accurate, chronological and well written narrative.
- Processed product quality complaints.
- Generate CIOMS reports to perform quality analysis of processed reports.
Drug Safety Specialist
Sunovion
Marlborough, Massachusetts
07.2021 - 07.2022
- Accurate entry of adverse events and special situations into Argus Database.
- Performs a duplicate check and the validity of the case using four important criteria for ICSRs.
- Assessment of the seriousness of events, coding events, and medical history using MedDRA.
- Perform peer Quality control (QC) review of case entry to Safety database and document discrepancies and make corrections.
Education
Bachelors of Dental Surgery - Dentist
AJ Institute of Dental Sciences
Mangalore, Karnatake, India10-2019
Skills
- Adverse event reporting
- MedDRA coding
- Quality control review
- Regulatory compliance
- Case documentation
- Report generation
- Attention to detail
- Problem-solving abilities
- CIOMS report generation
- Effective communication
- Time management
- FLUENT IN ENGLISH
Affiliations
- Professional classical dancer
- Advance level Yoga
- Swimming
Languages
Kannada
First Language
English
Proficient (C2)
C2
Hindi
Intermediate (B1)
B1
Accomplishments
- Cultural secretary of student council.
Certification
- Advance Drug Safety and Pharmacovigilance.
Timeline
Product Safety Specialist
Eisai
08.2022 - 11.2024
Drug Safety Specialist
Sunovion
07.2021 - 07.2022
Bachelors of Dental Surgery - Dentist
AJ Institute of Dental Sciences
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