Dara Vinay

About Dara Vinay

As a Drug Safety Specialist with experience in Pharmacovigilance, I am passionate about…

Experience

1. Drug Safety Associate 1

   Qinecsa Solutions

   Feb 2021 — Present · IN

   Currently working as a Case Processor and Reviewer at Qinecsa (formerly Bioclinica), I am responsible for ensuring the validity of case data and entering individual case safety reports into the safety database. I review and evaluate adverse event case information to determine the required action based on internal policies and procedures. I process all incoming cases to meet timelines and code products specified as suspect or concomitant by the reporter. Additionally, I enter and code case data, including event, seriousness, reported casuality, medical history, and laboratory data as provided by the reporter.\\\\n\\\\nAs a Peer Reviewer, I evaluate case accuracy, consistency, and completeness in the safety database against source documents. This includes checking consistency of narrative and other data fields, ensuring that the main reason for any delay is entered in the routing comment as appropriate. I review adverse event report data for completeness and verify certain fields to determine as critical, as well as conformity to E2B standards. I also track and document all observations and recommendations on the defect tracker.\\\\n\\\\nMoreover, as a Medical Coder, I am responsible for coding all medical history, events, drugs/procedures/indications, and laboratory tests according to the appropriate dictionary, such as MedDRA, Company product dictionary, or WHO-DD. Additionally, I am responsible for writing medically relevant safety narratives of cases and checking the completeness and accuracy of the data entered in various fields.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Education

• CMR College of pharmacy

  Bachelor's degree, Pharmacy

  2011 — 2015

• Swami vivekanada institute of pharmaceutical sciences

  Master's degree, Pharmacy

  2015 — 2017