Ahammed Unais

Master of pharmacy graduate (2019-2021 batch) from Delhi Pharmaceutical Sciences and Research University, India, having strong research experience in the field of drug discovery & development and in Scientific/Medical writing. Currently working as Drug Safety Research Associate at Parexel International, India.

Drug Safety Associate - I • Parexel International, India • November 2021–Till date

• Management of ICSRs of various case types (spontaneous, clinical studies and solicited programs).
• Well versed with Pharmacovigilance concepts and Reporting guidelines of ICH, GVP and CIOMS.
• Participated in the case review process applying a high standard of quality review to ensure sound medical safety data documentation.
• Knowledge of Case Triage, Case Narrative writing, Scientific/Medical writing, performing Labelling/ Listedness and Causality determination.
• Learnt about Medical Coding (MedDRA) of adverse events, indications, and Medical history.

• writing deliverables for Medical Affairs communications (slide decks, patient or HCP materials, etc)

 Project Internship • Indian Pharmacopoeia Commission • Mar 2021- August 2021

• Assisted various drug analysis projects in HPLC, UV & IR spectroscopy
• Carried Method Development & validation, Assays, Quality Control in HPLC
• Sample preparation for HPLC, Dissolution test, Disintegration test, Karl-Fischer titration UV & IR spectroscopy 

Internship • Sami Labs • June – July 2018

• Trained at R&D, Formulation and QA-QC departments.
• Assisted drugs Analysis in Column Chromatography

M. S. Pharm in Pharmaceutical Quality AssuranceDelhi Institute of Pharmaceutical Sciences and Research • New Delhi • 2021 August • 3.3 GPA

Bachelor of Pharmacy (B. Pharm)Government Medical college • Thiruvananthapuram, Kerala, India • 2018 • 3 GPA