Mohit Shekhar

About Mohit Shekhar

Detail-oriented, methodical, goal-driven and self-motivated drug safety professional offering over 8+ years of expertise in Pharmacovigilance including triage, case initiation, medical regulatory assessment, data entry, data validation and quality check. • Expertise in managing Individual Case Safety Reports (ICSRs) of various case types (spontaneous, Clinical studies,Non-interventional studies, literature review and retrospective programmes, also well versed with Argus, medDRA (coding), medical device product complaint (handling), narrative writing.• Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents, writing case summaries, assessing causalities if required and writing company comment if required. Conducting duplicate searches prior to registration and identifying potential duplicates.Trained in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”.• Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, Volume 9A, CIOMS, New EU PV legislation).• Managing safety data on various safety databases (ARGUS, Veeva Safety Vault, ARISg and SCEPTRE).• Skilled in MS office, MS outlook and internet specific tools.

Experience

1. Operational Specialist 1

   IQVIA

   Oct 2020 — Present · Kochi, IN

Education

• Pioneer Montessori Inter College

  Secondary School Certificate(SSC), Science

  2004 — 2005

• Pioneer Montessori Inter College

  Higher Secondary Certificate (HSC), Science

  2006 — 2007

• Lovely Professional University

  Master of Technology (M.Tech.), Biotechnology

  2013 — 2015

• Integral University, Lucknow, Uttar Pradesh

  Bachelor of Technology (B.Tech.), Biotechnology

  2009 — 2013

Skills

• Biotechnology