Deepak Yadav

About Deepak Yadav

An experienced drug safety specialist with 04 years experience in management of Novartis, Sanofi, Merck KGaA Individual Case Safety Reports (ICSRs)/ Literature Screening/ Safety review which includes:Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities.Book-in of ICSRs into the safety database.Responsible for conducting duplicate searches prior to book-in and identifying potential duplicates.Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SmPC, CDS, IB etc.), writing case summaries, case narrative, assessing causalities if required and writing CIOMS comments if required.Data validation that is cross checking against source documentation.Experienced in MedDRA coding in accordance with MedDRA Term Selection: Points to Consider.Experienced in Veeva Vault RIM.Maintaining a good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including: ICH guidelines on safety and efficacy FDA guidelines CIOMS New EU PV legislationResponding to clients/customers in a timely manner.Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.Literature experience: Experienced in processing literature cases from medical journals including abstracts, poster presentation, literature summary cases and full text articles and communicating with the authors for the required information on the articles.

Experience

1. Associate Pharmacovigilance Specialist

   Clarivate

   Jul 2023 — Present · Noida, IN

Education

• Maharshi Dayanand University

  M.pharmacy

  2019 — 2021

• Maharshi Dayanand University

  Bachelor of Pharmacy - BPharm

  2015 — 2019