RAJESH BHATI
PALI
Summary
Pharmacovigilance professional with expertise in literature review, MedDRA coding, narrative writing, and case processing with global regulatory standards. Adept at triaging, medical literature monitoring (MLM), and mentoring new team members. Proficient in safety databases including Argus, PLI, and Veeva Vault. Passionate about driving drug safety, compliance, and regulatory excellence.
Overview
3
3
years of professional experience
Work History
Senior Process Associate
Tata consultancy Services
Gandhinagar
06.2023 - 05.2024
- Conducted systematic literature reviews using PLI Database to identify adverse drug reactions.
- Performed literature indexing and case booking in the Argus Safety Database, ensuring compliance with global regulatory requirements.
- Utilized the LRT tool for literature screening and extraction, streamlining drug safety monitoring.
- Reviewed docuent with help of Company Core Data Sheets (CCDS).
- Applied MedDRA coding for accurate classification of adverse events.
- Processed translation requests and full-text (FT) orders to support comprehensive literature analysis.
- Coordinated author follow-ups to gather essential case details and clarifications.
- ICH-GCP Guidelines
1. Ensured compliance with ICH-GCP guidelines in case processing and literature surveillance.
2. Participated in pharmacovigilance audits and inspections, ensuring adherence to Good Clinical Practice (GCP) standards. - Training to new joiner regarding process/workflow.
Pharmacovigilance Officer
Emcure Pharmaceuticals Limited
Gandhinagar
07.2021 - 06.2023
- Triaged ICSRs from regulatory authorities (MHRA, EudraVigilance, Health Canada, TGA), literature, and spontaneous reports.
- Conducted literature reviews using PubMed and Embase for case identification.
- Processed and booked cases in Argus Safety Database, ensuring accuracy.
- Authored detailed case narratives, providing clear and comprehensive safety insights.
- Performed Medical Literature Monitoring (MLM) Review, supporting global pharmacovigilance efforts.
- Trained and mentored new team members on SOPs, workflow processes, and case handling best practices.
- Allocated and tracked ICSR cases, optimizing workflow efficiency.
- Conducted causality assessments and seriousness determination for ICSRs following regulatory guidelines.
Education
Master Degree: Master of Pharmacy- Pharmacology -
Institute of Pharmacy, Nirma University
Ahmedabad, Gujarat, India04.2021
Bachelor Degree: Bachelor of Pharmacy -
Lachoo Memorial College of Science And Technology
Jodhpur, Rajasthan, India04.2019
Academic Qualifications -
Sr. Secondary & Secondary
Skills
- Pharmacovigilance & Drug Safety Literature Review (PubMed, Embase, MLM)
- Case Processing & ICSR Management
- Case Triaging (Regulatory, Literature, Spontaneous)
- MedDRA Coding & Narrative Writing
- Medical Literature Monitoring (MLM)
- Case Identification and Triaging of Regulatory {MHRA/EU vigilance/Health Canada/TGA}, Spontaneous, Literature cases
- Safety Databases: Argus, PVEdge, Veeva Vault, LRT Tool
- Company Core Data Sheets (CCDS) & Document Management
- Training & Mentorship for New Joiners
- Literature indexing
- Causality assessment
Accomplishments
- Project Title- Neuroprotective effect of Ulva Lactuca Extract against Cognitive Deficits and Anxiety like behavior in Rats.
- Training - Industrial training at Cadila Pharmaceuticals Limited for 3 months in the CRO
department (from 17/Aug/20 to 11/Nov/20).
Co-Curricular Activities and Achievements
- Working on a review article- Insights into Therapeutic Perspectives of Prion’s
Disease. - Poster Presentation of review topic (UNRAVELING THE MYSTERY of PRION DISEASE: GENE—ENVIRONMENT CROSSTALK?) at International Conference on Integrating Chemical, Biological and Pharmaceutical Sciences for Innovation in Health Care held at Institute of Pharmacy, Nirma University during 22-24 January 2022
- Attended International Conference on Integrating Chemical, Biological and Pharmaceutical Sciences for Innovation in Health Care held at Institute of Pharmacy, Nirma University during 22- 24 January 2020
- Attended workshop on Pharmacovigilance conducted by Department of Pharmacology, Institute of Pharmacy and Institute of Clinical Research India, Ahmedabad from 3-5 October 2019
Extra-Curricular Activities and Achievements
- Certificate of participation from CSMCRI, Bhavnagar, Gujarat.
- Certificate of Completion Corona virus disease 2019 by Harvard Medical School.
- Participation in various Photography contest.
Hobbies
Photography, Traveling, Listening to music, Hiking
Languages
- English, Hindi, Gujarati, Rajasthani
Timeline
Senior Process Associate
Tata consultancy Services
06.2023 - 05.2024
Pharmacovigilance Officer
Emcure Pharmaceuticals Limited
07.2021 - 06.2023
Master Degree: Master of Pharmacy- Pharmacology -
Institute of Pharmacy, Nirma University
Bachelor Degree: Bachelor of Pharmacy -
Lachoo Memorial College of Science And Technology
Academic Qualifications -
Sr. Secondary & Secondary
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