Submission Specialist

4 days ago


Mumbai, Maharashtra, India Unichem Laboratories Full time ₹ 3,00,000 - ₹ 4,50,000 per year

RESPONSIBILITIES

  • Book-in, Data Entry and Quality Reviewer of ICSR in Argus database
  • ICSR Global Submission (Timelines and Submission Process)
  • Vendor Management
  • SOP training in department as and when needed

DESIRED SKILLS

  • Good knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines.
  • Good knowledge about timelines and submission process of Global ICSRs w.r.t to multiple health authorities.
  • Good knowledge about Global submission mailbox, maintenance of submission data and trackers of all ICSR submission activities including correspondence with regulatory authorities and submission records for audits and inspection readiness.
  • Basic knowledge of Computers
  • Good Communication skills


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