Responsibilities

  • Perform case processing in the Safety Database
  • Downloading ICSR from different HRA portals
  • Triaging of ICSRs
  • Process MLM / Regulatory authority / 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
  • Client communication

Education

Pharmacist or life science or Dentist or Nurse

Required experience

  • 2-8 years PV post marketing case processing experience
  • Knowledge of GVP especially module VI, ICH E2B guidelines
  • PV database experience

Additional Skills

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

Case Specialist-902