Responsibilities

  • Perform case processing in the Safety Database
  • Downloading ICSR from different HRA portals
  • Triaging of ICSRs
  • Process MLM / NCA / Literature cases in the Safety Database
  • Submission of cases to EMA / MHRA / USA
  • Effectively tracking ICSRs and maintaining ICSR tracker
  • Provide support in audits and inspections

Education

Pharmacist or life science or Dentist

Required Experience

0-4 year of experience in Pharmacovigilance

Technical Skills

Basic understanding of Pharmacovigilance case processing, GVP
module VI and CIOMS

Additional Skills

  • Excellent oral/written English communication
  • Good knowledge of MS office (Word/Excel/PowerPoint)

Data Officer 901