CURRICULUM VITAE
Name: Ashutosh Lahre
Phone: +91-9179305792
Email id :
[email protected]LinkedIn : https://www.linkedin.com/in/ashutosh-lahre-6a8a77304
Professional Summary:-
Enthusiastically seeking to begin my career in Pharmacovigilance, backed by Certification Training (July
2025) with expertise in Oracle Argus, VigiAccess, VigiBase, VigiFlow, EudraVigilance, MedWatch, and
MedDRA coding. B.Pharm (2025) graduate with hands-on experience in ICSR case processing,
seriousness/expectedness assessment, narrative writing, causality assessment (Naranjo Algorithm), and
signal detection (PRR analysis). Skilled in case follow-up, safety report preparation, and ensuring
compliance with ICH-GCP, ICH-GVP, US FDA, EMA, and CDSCO guidelines. Committed to Good
Documentation Practices (GDP), data integrity, and audit readiness.
Education:-
Bachelor of Pharmacy (B.Pharm) (2022-2025)
Guru Ghasidas Vishwavidyalay, Bilaspur, Chhattisgarh, India
CPGA: 7.22/10
Certifications & Training:-
Professional Certificate in Pharmacovigilance & Medical Coding – Learn Medicine Professional
Certifications (June–July 2025)
ADR reporting, ICSR processing, narrative writing, seriousness/expectedness assessment.
Signal detection, risk assessment, aggregate reporting (PSUR, SUSAR).
ICD-10-CM, CPT, HCPCS, DRG, HCC coding systems, anatomy, and medical terminology.
Core competencies
Pharmacovigilance & Drug Safety
Daily case processing of clinical trial and post-marketing adverse events with MedDRA coding.
Preparation and peer review of ICSRs, SUSARs, and PSURs.
Narrative writing and follow-up information collection in line with SOPs and client specifications.
Signal detection, causality assessment, and literature search for ADR monitoring.
Knowledge of Risk Management Plans (RMPs) and aggregate safety reporting.
Strong understanding of ICH E2E, ICH-GVP, ICH-GCP, and global safety regulations (US FDA,
EMA, CDSCO).
Adherence to GDP standards ensuring quality, consistency, and audit compliance.
Software & Tools
Oracle Argus, VigiAccess, VigiBase, VigiFlow, EudraVigilance, MedWatch, OpenVigil.
Medical literature databases (PubMed, Medline, Google Scholar, MedPix).
Microsoft Office Suite (Word, Excel, PowerPoint).
Soft Skills
Attention to detail | Strong verbal & written communication | Time management | Team collaboration
Internships:
Clinical Data Management & Clinical Research, Learn Medicine Professional Certifications (June
2025):
Acquired practical exposure to CDM processes, clinical trial documentation, and data validation in line with
ICH-GCP standards.
Industry Internship – Deepti Pharmaceuticals Ltd., Nagpur (May–Jun 2024):
Assisted in QA & Regulatory Affairs, preparing regulatory documents for drug approval and gaining exposure
to GMP and quality control testing.
B.Pharm Research Project:-
Guru Ghasidas University (2024–2025):
Survey on Emergency Medicines: Assessed pharmacy stock, storage, and supply chain gaps for life-
saving drugs.
Animal Handling: Gained hands-on experience in dosing, weighing, observation, and ethical
preclinical practices.
Languages:-
• English (Fluent)
• Hindi (Fluent)
Declaration:-
I hereby declare that the above information is true to the best of my knowledge and belief.
ASHUTOSH LAHRE
