I am Vaibhavi Shinde. Currently undergoing PV certification internship program as Trainee Pharmacovigilance Associate (Zyfis Life Sciences Private Limited, From FEB 2023 till Present)
Experience
Hands on experience of Case Intake, Data Entry of ICSR on Safety database “ARS”
(Advanced Reporting System).
Expertise in processing Spontaneous, Regulatory, Literature & Clinical Trial Cases.
Hands on of mailbox handling, receipt, evaluation & assessment of source document for the presence of a valid ICSR.
Trained on ICSR case Intake Team responsibilities such as triaging & prioritizing the ICSRs based on source of the reports, seriousness, causality & labelling under a definedregulatory timeframe
Performing Case Intake by adding mandatory parameters in Safety Database.
Accurate MedDRA codingof adverse events, medical history & laboratory data.
Writing perfect, chronological, and concise medically relevant safety narratives for different types of ICSRs.
MICC Affiliate
Education
B. Pharmacy: Passed-Out in the year of 2023 from N. N. Sattha College of Pharmacy Ahmednagar.
Passed out 12th in 2019 from Pune Divisional Board .
Marks 66.31 %
Passed out 10th in 2017 from Pune Divisional Board.
