Monish S
Chengalpattu
Summary
- Pharmacovigilance Senior Analyst with expertise in ICSR processing, functioning as Subject Matter Expert (SME) dedicated to training new hires and maintaining quality control standards.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Senior Analyst
Accenture Solutions Pvt Ltd
Chennai
07.2019 - Current
- Processing of Individual Case Safety Reports (ICSRs) and managing adverse events, as well as other safety information from various sources, including clinical trials, post-marketing (Phase IV and spontaneous), along with literature reports, which involve patient support programs, market research, business partners, and other different vendors, etc.
- Managing adverse events from various sources, ensuring appropriate serious outcome criteria, term selection, listedness, relatedness/causality assessment, and availability for medical review.
- Ensuring the completeness and accuracy of data management, and associated case management activities.
- Medication and History: Identification of concomitant medication and relevant medical history.
- Verifying and coding of the Company drug dictionary (CDD), the WHO drug dictionary (WHODD), and MedDRA in the safety database.
- Drafting a narrative which acts as a summary of case (patient) details and performing follow-up by letter attachment or correspondence
- Expanding expertise on case collection and expedited reporting requirements from major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA, etc.).
- Applying clinical judgment, critical thinking, and regulatory knowledge to manage adverse event data, ensuring data integrity, consistency, and compliance.
- Complying with internal and external timelines for managing adverse event data entry, and proactively managing incoming work, prioritizing, and collaborating with global colleagues to ensure timelines are met.
- Maintaining an understanding of Pharmacovigilance Agreements (PVA), and assessing the labeling documents based on the country of reported cases for assigned products.
Education
M.Pharm - Pharmacy
SRM College of Pharmacy
Kattankulathur, Tamil Nadu05-2019
Skills
- ICSR case processing
- WHO DD coding
- MedDRA coding
- Causality assessment
- Labeling assessment
- Narrative writing
- Medical terminology
- Database management (LSMV and ARGUS)
- Communication skills
- Interpersonal skills
- Materials analysis
Languages
Tamil
First Language
English
Proficient (C2)
C2
Tamil
Proficient (C2)
C2
Telugu
Advanced (C1)
C1
Accomplishments
- Spot award as recognition for the true testimony to my work and efforts, and quality champion in August and November 2023 at Accenture Solutions Pvt., Ltd
- Encore Award (Core Value Champion) – Honored for embodying core values and excellence, awarded for H2 FY24 at Accenture Solutions, Pvt. Ltd.
Certification
- PG project: Green synthesis of silver nanoparticles using Wrightia Tinctoria plant extract for the treatment of psoriasis
- Review article: Monish S, Sangeetha S, Damodharan N. Green synthesis of nanoparticles and its applications; DIT:2018 Special Issue,Vol. 10, p3324-3334. 11p
Timeline
Pharmacovigilance Senior Analyst
Accenture Solutions Pvt Ltd
07.2019 - Current
M.Pharm - Pharmacy
SRM College of Pharmacy
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