Alvira Ashraf

Background

About Alvira Ashraf

As a seasoned Pharmacovigilance Specialist with over 5 years of experience in major pharmaceutical corporations, I possess comprehensive expertise across the entire spectrum of pharmacovigilance processes. My background includes reporting adverse events and product quality complaints, managing end-to-end ICSR data entry, and conducting rigorous quality checks and analysis of medical safety documents. I am skilled in the development and implementation of Standard Operating Procedures and corrective action plans, with a strong focus on ensuring compliance with Canadian Adverse Event reporting guidelines and Good Pharmacovigilance Practices. I have a solid foundation in clinical research, pharmaceutical, and medical device domains, with extensive experience in data management and safety data review plans. My expertise extends to coding using the MedDRA dictionary for medical histories and concomitant diseases, as well as the WHO drug dictionary for concomitant medications and therapies. I am adept at ensuring the accuracy, completeness, and consistency of clinical trial reports and laboratory data collection. With a Master’s degree and a proven ability to manage multiple projects independently, I excel in clinical safety data processing, data validation checks, and clinical trial safety data coding and management.