AVINASH DUBEY
📞 - | ✉️-📍 Moga, Punjab, India
PROFESSIONAL SUMMARY
Motivated and detail-oriented Drug Safety Associate with experience at Parexel International, currently involved in managing Individual Case Safety Reports (ICSRs) across various case types including spontaneous, clinical trial, solicited, and literature reports. Familiar with global pharmacovigilance regulations including ICH, FDA, and EU PV legislation. Skilled in using Oracle Argus and Veeva Vault for pharmacovigilance workflows. Possess strong analytical, documentation, and communication skills with a solid foundation in pharmaceutical sciences.
PROFESSIONAL EXPERIENCE
Drug Safety Associate I
Parexel International, Chandigarh, India | June 2024 – Present
- Under training for processing ICSRs through the Global ICSR Automation tool.
- Gaining hands-on experience in managing spontaneous, clinical, solicited, and literature cases.
- Performing triage to determine expedited reporting criteria and regulatory timelines.
- Conducting data validation and cross-checking source documents.
- Maintaining working knowledge of safety profiles, RSI documents, and global safety regulations (ICH, FDA, CIOMS, EU PV).
EDUCATION
M. Pharm. in Pharmaceutical Quality Assurance
ISF College of Pharmacy, Moga, Punjab | 2024 | CGPA: 8.51
- Thesis: Development of TPGS-Based Liposomal Formulation to Combat Antimicrobial Resistance
- Supervisor: Prof. Balak Das Kurmi
B. Pharm.
SSR College of Pharmacy, Silvassa | 2022 | CGPA: 7.989
PUBLICATIONS
Sr No
Title
Journal
Status
1
Empowering Antimicrobial Peptides: Harnessing Nanotechnology and Engineering Strategies to Combat Microbial Resistance
Peptide Science-Wiley
Published
2
Advancements in Nanoparticle-Based Gene Delivery Systems for Therapeutic Applications: A Comprehensive Review
International Journal of Newgen Research in Pharmacy & Healthcare
Published
3
A Comprehensive Review on Doxorubicin: Mechanisms, Toxicity, Clinical Trials, Combination Therapies and Nanoformulations in Breast Cancer
Drug Delivery and Translational Research- Springer Nature
Published
4
Miscellaneous Targeting Approaches: Fundamentals of Gene Delivery and Overview of Colon, Liver, Macrophage, Mitochondrial, and M-Cell Targeting
Novel Carrier Systems for Targeted and Controlled Drug Delivery
Published
TECHNICAL & COMPUTER SKILLS
- Pharmacovigilance Tools: Oracle Argus, Veeva Vault
- Case Processing: ICSR management, MedDRA coding, triage, data validation
- Regulations: ICH E2B, GVP modules, FDA and EU PV guidelines
- Documentation: Narrative writing, RSI interpretation, QC review
- Computer Skills: Microsoft Office Suite (Word, Excel, PowerPoint), EndNote, Design Expert, Biorender
- Lab Equipment Knowledge: HPLC, FTIR, UV-Vis Spectroscopy, DSC
CERTIFICATIONS & ACHIEVEMENTS
- GPAT Qualified – AIR 988 (2022)
- Oral presenter at PHARMA ANVESHAN 2024
- Participated in GLP Workshop – ISF College of Pharmacy
LANGUAGES
English: Fluent
Hindi: Fluent
