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Ahammed unais

Ahammed unais

Drug Safety Associate

Healthcare

Malappuram, Malappuram

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About 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.

Experience

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.

Understanding of Drug Development Process including Drug safety and different Phases of Clinical Trials.

  • 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

 

Education

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

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