Submission Specialist - Pharmacovigilance

2 - 6 years

3 - 8 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

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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Unichem Laboratories logo
Unichem Laboratories

Pharmaceuticals

Mumbai

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